Evaluation of Surgical Condition During Laparoscopic Gynaecological Surgery in Patient With Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum
Phase: NA
Conditions: Gynecologic Disease, Neuromuscular Blockade
Sponsor: Universiti Sains Malaysia

Page 1 of 48   
  
  
STUDY PROTOCOL:  
EVALUATION OF SURGICAL CONDITION DURING  
LAPAROSCOPIC GYNAECOLOGICAL SURGERY IN PATIENT 
WITH MODERATE VS DEEP NEUROMUSCULAR BLOCK IN 
LOW PRESSURE PNEUMOPERITONEUM.  
    
Researcher: DR UMAIRAH BINTI ESA ( MMC 71514)  
 
Co-researchers:   
  
ASSOCIATE PROF DR RHENDRA HARDY B MOHAMAD  
ZAINI (MMC 32241, NSR 126684 ).  
DR ZULFAKAR MAZLAN (MMC 46464, NSR: 132658)  
DR SANIHAH CHE OMAR (MMC 44833, NSR: 132654)  
DR AHMAD AKRAM OMAR (MMC 46516, NSR 130133)  
  
JEPeM Code : USM/JEPeM/20080410  
  
6  March 2021 
  
  
  
 
 

Page 2 of 48   
CONTENTS:  
1. 
Introduction   
  
  
  
  
  
  
  
Pg 3  
2. 
Problem statement and study rationale   
  
  
  
Pg 4  
3. 
Research questions  
  
  
  
  
  
  
Pg 4  
4. 
Objectives     
  
  
  
  
  
  
 
Pg 5  
5. 
Literature review     
  
  
  
  
  
 
Pg 5-7  
6. 
Conceptual frameworks     
  
  
  
  
 
Pg 8  
7. 
Research design    
  
  
  
  
  
  
Pg 9-10  
8. 
Subject Criteria  
  
  
  
  
  
  
  
Pg 10  
9. 
Sample size calculation     
  
  
  
  
 
Pg 8-10  
10. 
Sampling method and subject recruitment    
  
  
Pg 13-14  
11. 
Operational definition  
  
  
  
  
  
  
Pg 15  
12. 
Data collection method, research tools and data analysis    
Pg 17-20  
13. 
Study flow chart    
  
  
  
  
  
  
Pg 20-22  
14. 
Gantt chart and milestone  
  
  
  
  
  
Pg 23  
15. 
Ethical consideration  
  
  
  
  
  
 
 Pg 23-24 a. 
Subject vulnerability b. Declaration of absence of conflict of interest c. Privacy and 
confidentiality d. Community sensitivities and benefits e. Honorarium and 
incentives  
16. 
References     
  
  
  
  
  
  
 
Pg 25-27  
17. 
Patient information sheet and Consent form    
  
  
Pg 29-35 
18. 
Curriculum vitae     
  
  
  
  
  
 
Pg 36-48 
  
  
 
 
  
  
  

Page 3 of 48   
1-Introduction  
  
Laparoscopic surgery has increasing popularity and slowly replacing conventional open 
surgery as it offers more benefit to patient and health care practitioner. The overall risk of 
complications during laparoscopic surgery is recognized to be lower than during laparotomy. 
Laparoscopic hysterectomy compare to open vaginal hysterectomy reduces postoperative pain, 
reduce post op analgesics requirement and shorter duration of hospital admission.1  
However, the increase intra-abdominal pressure created during laparoscopic surgery 
can affect cardiovascular, pulmonary and renal physiology. Besides the risk of post-operative 
nausea and vomiting, it is also stated that the pneumoperitoneum created during laparoscopic 
surgery is an important factor in the cause of postoperative shoulder pain.2 Traditionally 
pneumoperitoneum created at 15mmHg3. Insufflation of intraabdominal carbon dioxide may 
cause post‐operative shoulder pain up to 70% in some study in gynaecologic laparoscopic 
surgery. 4   
Use a lower pressure pneumoperitoneum might decrease postoperative pain, decrease 
post-operative shoulder tip pain5 and reduce the risk of laparoscopic related complication6. 
Many studies used lower insufflation of intraabdominal pressure as an intraoperative 
intervention to reduce the complication7,8.  However, a lower intraabdominal pressure may 
worsen surgical space and increase the risk of conversion to open surgery.  
 Though many factors contribute to the quality of surgical space include non-modifiable 
such as obesity, previous abdominal surgery and modifiable factors such as anaesthesia related 
factor, patient position and intraabdominal pressure. Numerous studies also have been carried 
out showing that deep neuromuscular block improves surgical condition in different type of 
laparoscopic surgery includes robotic assisted laparoscopic surgery.9,10,11  
Currently with the advancement of technology where neuromuscular monitoring is 
widely available and the selective reversal binding agent suggamadex where post-operative 
complication of inadequate reversal can be markedly reduced, several studies have been done 
to observe the benefit of low intraabdominal pressure with deep neuromuscular block to 
surgical space quality and intraoperative complication related to high pressure intraabdominal 
complication compare to usual moderate block.9,10,12 However there is still few study 
objectively measure the possible effect of deep neuromuscular blocker on the surgical space 
and the ability of surgery to be completely done in low pressure pneumoperitoneum in 
laparoscopic gynaecological surgery.   
We hypothesized that deep neuromuscular block compare to moderate neuromuscular 
block would reduce the rate of increasing intraabdominal pressure and con be completely done 
in lower pressure pneumoperitoneum and would improve laparoscopic space by measuring 
distance from the sacral promontory to the inserted trocar in patients undergoing laparoscopic 
gynaecological surgery.  
  

Page 4 of 48   
2-Problem statement & Study rationale  
  
• 
Laparoscopic surgery increases tremendously in the past decade in the era of enhance 
recovery after surgery ( ERAS) , despite its many advantages increase intraabdominal 
pressure by intraabdominal carbon dioxide inflation produce respiratory, cardiac side 
effect.   
• 
There are previous studies done that show deep neuromuscular blockage in laparoscopic 
surgery increase quality of surgical view in upper abdominal surgery, bariatric surgery, 
and extraperitoneal surgery like nephrectomy.   
• 
However, there is still not enough study to prove superiority of deep neuromuscular 
block compare to moderate neuromuscular block.   
• 
Therefore, further studies are still required to evaluate the benefit of deep neuromuscular 
block   
  
3-Research question  
1. Is maintaining laparoscopic gynaecological surgery with deep neuromuscular block, 
(PTC 0-1) reduce the rate of increasing intra-abdominal pressure to maintain optimal 
surgical conditions compare to patient receiving moderate neuromuscular block (PTC 
>2)  
2. Is maintaining laparoscopic gynaecological surgery with deep neuromuscular block, 
(PTC 0-1) increase skin-sacral promontory distance compare to patient receiving 
moderate neuromuscular block (PTC >2)  
3. Is maintaining laparoscopic gynaecological surgery with deep neuromuscular block, 
(PTC 0-1) provide better surgical space quality compare to patient receiving moderate 
neuromuscular block PTC >2   
4. Does maintaining lower abdominal laparoscopic surgery with deep neuromuscular 
block, PTC 0-1 reduce post-operative pain and reduce post-operative shoulder tip pain 
compare to patient receiving moderate neuromuscular block PTC >2?  
  
  
  
  
  

Page 5 of 48   
4-Objective  
• General:.  To evaluate the effect of deep neuromuscular blockade on surgical conditions 
during laparoscopic gynaecological under low-pressure pneumoperitoneum.  
Specific:  
1. To compare the rate of increasing intra-abdominal pressure (IAP) by the surgeon when 
they decide that the surgical conditions are inadequate for the operation in patient 
receiving deep neuromuscular block compare to moderate neuromuscular block in 
laparoscopic gynaecological surgery.  
2. To compare quality of surgical space condition in patient receiving deep and moderate 
neuromuscular block in laparoscopic gynaecological surgery.  
  
3. To compare skin to sacral promontory distance in patient in patient receiving moderate 
neuromuscular block and deep neuromuscular block in laparoscopic gynaecological 
surgery.  
4. To compare the post-operative pain and shoulder tip pain in patient receiving deep 
neuromuscular 
block 
and 
moderate 
neuromuscular 
block 
in 
laparoscopic 
gynaecological surgery  
  
5-Literature review  
In the past decade, many studies have been done to evaluate the benefit of deep 
neuromuscular blocker in many types of laparoscopic surgery such as to the surgical space 
quality, duration of operation, post-operative pain and intraoperative complications.  
Dubois et. Al in 2014 compare the surgical condition in deep neuromuscular block and 
shallow neuromuscular block in laparoscopic hysterectomy using 4-point surgical scale. It 
shows that better surgical rating scale in deep neuromuscular block. In 98 of the subjects 34 of 
subject show excellent surgical condition where only 21 patients in shallow group score 
excellent.  
Madsen et. All had done multiple randomized controlled trial in 2015 and 2016 
evaluating different outcome comparing deep neuromuscular block and moderate 
neuromuscular block in laparoscopic gynaecological surgery. In 2015, they investigated 
whether deep neuromuscular block compared with no neuromuscular block would increase 
surgical space by measuring distance from sacral promontory to the inserted trocar at 
pneumoperitoneum of 12 mmHg and 8mmHg11. At 12 mmHg pneumoperitoneum, deep 
neuromuscular block improved surgical space with a mean of 0.33 cm (95% confidence interval 
0.07–0.59) (P  = 0.01) which is statistically insignificant but at 8mmHg deep neuromuscular 
block significantly improved surgical space with a mean of 0.3 cm (95% confidence interval, 
0.06–0.54) (P  = 0.005). in this study, surgical condition during suturing fascia in deep 

Page 6 of 48   
neuromuscular block is significantly better compare to moderate block(p=0.03) estimated by 
the gynaecologist on a 4‐point subjective rating scale.  
In the next randomized controlled study, Madsen study the incidence of post-operative 
shoulder tip pain and recovery after laparoscopic hysterectomy in low pressure 
pneumoperitoneum 8mmHg with deep neuromuscular block (post tetanic count 0 to 1) 
compared with standard-pressure pneumoperitoneum (12 mmHg) with moderate 
neuromuscular block. In this study the incidence of shoulder tip pain is significantly reduce in 
group lower pneumoperitoneum with deep neuromuscular block (p = 0.34) after 4 days but 
after 14 days, the p value is 0.74 which is insignificant.14  
Meta-analysis in 2017 by M. H. Bruintjes include seven studies pooled in analyses 
surgical space condition. Overall surgical space condition improved in deep neuromuscular 
block by mean difference of 0.65 (95% CI: 0.47–0.83) on a scale of 1–5. Between study 
heterogeneity was 46%.  In this meta-analysis also, 5 studies pooled to analyse post-operative 
pain in the post anaesthesia care unit (PACU) during the first hour after surgery, which show 
overall significant reduction of early postoperative pain in the group with deep neuromuscular 
blockage by mean difference 0.52 (95% CI: −0.71 to − 0.32) on an 11-point scale. 15  
Subsequent meta-analysis in 2018 by park et al analyse eleven RCTs involving 844 
patients. The frequency of excellent or good operating conditions was higher with deep block 
compared with a moderate block (odds ratio 2.83, 95% confidence interval 1.34 to 5.99, P = 
0.007, I2 = 59%). However further studies are required to address the heterogeneity.16   
Recent meta-analysis in 2020 includes eight study in analysis of the surgical space 
conditions which provides evidence that low intraabdominal pressure+ deep neuromuscular 
block does improve surgical space conditions compared with low intraabdominal pressure + 
moderate neuromuscular block however there is no difference in post-operative pain and 
duration of surgery. 17 However different intraabdominal pressure uses and degree of 
neuromuscular blocker use is different which make the study cannot have a solid conclusion 
which protocol is more preferable. All meta analysis conclude that we still need further 
randomized controlled studies are warranted to address the heterogeneity and power shortage 
demonstrated by the meta-analysis.  
  
  
  
  
  
  

Page 7 of 48   
Article 
code 
[no.]   
Laparoscopic 
procedure   
NMB  
level 
experimental 
group   
NMB level  
control 
group   
Number of  
patients   
Surgical 
rating 
scale   
Other  outcome 
measure  
Dubois  
13 
2014  
Hyst   
Deep   
Shallow   
100   
1–4   
Duration   
Martini  
201418  
Prost/Nephr   
Deep   
Moderate  
24   
1–5   
Duration, 
 
pain, comp  
Staehr- 
Rye  
19 
2014   
Chol   
Deep   
Moderate  
48   
1–4   
Dur,  
pain, 
Intraabdominal 
pressure  
Yoo  
20 
2015  
Prost   
Deep   
Moderate  
66   
1–5   
Duration , pain, 
intraabdominal 
pressure comp   
Madsen  
9 
2015  
Gyn   
Deep   
No NMB   
14   
1–4   
Intraabdominal 
pressure  
Blobner  
21 
2015  
Chol   
Deep   
No NMB   
50   
0–100%   Duration, pain,    
Barrio  
22 
2016   
Chol/Gyn   
Deep   
Moderate   
41   
NA   
IAP, comp   
Kim  
9 
2016  
Colorectal   
Deep   
Moderate   
61   
1–5   
Dur, pain, LOS, 
IAP, comp   
Koo  
10 
2016   
Chol   
Deep   
Moderate   
64   
1–4   
Dur, pain, IAP, 
comp   
Madsen  
14 
2016  
Hyst   
Deep   
Moderate   
99   
NA   
Dur, pain, LOS, 
IAP, comp   
Torens 
ma  
23 
2016   
RYGB   
Deep   
Moderate   
100   
1–5   
Duration, pain   
Ozdemi 
r  
12 
2017   
Donor 
nephrectomy  
Deep  
Moderate  
34  
1-5  
Pain,  abdominal 
pressure  
  

Page 8 of 48   
 
  
  
  
  

Page 9 of 48   
7-Research design  
•  Study design   
: Single Centre, double blinded randomized controlled trial.  
In Hospital Universiti Sains Malaysia, we will randomize patient 
that fulfill inclusion criteria in a double-blind, randomize control 
trial comparing the rate of increasing intraabdominal pressure in 
low 
pressure 
pneumoperotoneum 
in 
laparoscopic 
gynaecological study.  
•  Sampling method  
: Simple random sampling  
Sample will be randomize either will be in moderate group or 
deep group by simple  Surgeon and participant will be blinded to 
the study either in moderate or deep groups.  
•  Study period   
: October  2020 – June 2022 (18 months)  
• 
Sampling time frame : October 2020 – October  2021(12 months)  
• 
Study location   
: Single center-Hospital Universiti Sains Malaysia, Kubang               
                                      Kerian, Kelantan  
  
Study area  
•  Study location: single center-Hospital Universiti Sains Malaysia, Kubang Kerian, 
Kelantan  
  
Study population  
• 
Reference population: Adult patient schedule to undergo laparoscopic gynaecological 
surgery (laparoscopic hysterectomy and laparoscopic ovarian cystectomy in Hospital 
Universiti Sains Malaysia , Kubang Kerian, Kelantan  
• 
Target population: Adult patient more than 18 years old schedule to undergo 
laparoscopic gynaecological surgery (laparoscopic hysterectomy and laparoscopic 
ovarian cystectomy in Hospital Universiti Sains Malaysia , Kubang Kerian, Kelantan   
• 
Sampling frame: Adult patient more than 18 years old, ASA I and  ASAII schedule to 
undergo laparoscopic gynaecological surgery (laparoscopic hysterectomy and 
laparoscopic ovarian cystectomy in Hospital Universiti Sains Malaysia , Kubang 
Kerian, Kelantan  
  

Page 10 of 48   
8-Subject criteria  
Inclusion criteria:  
1. Age more than 18 years old   
2. ASA I or II  
3. schedule 
to 
undergo 
laparoscopic 
gynaecological 
surgery 
(laparoscopic 
hysterectomy and laparoscopic ovarian cystectomy in Hospital Universiti Sains 
Malaysia , Kubang Kerian, Kelantan  
  
Exclusion criteria:  
1. Allergy to study drugs (rocuronium, suggamadex)  
2. Serious cardiac and respiratory disease (reactive airway disease, upper respiratory 
tract infection)  
3. Neurological or neuromuscular disease (epilepsy, family history and history of 
malignant hyperthermia etc.)  
4. Pregnancy  
5. Morbid obesity BMI>35  
  
Withdrawal criteria:  
1. Conversion to open surgery  
  
  
  
  
  
  
  
  
  

Page 11 of 48   
9- Sample size estimation  
  
Specific objective  
Statisticsal 
test  
Sample size determination  
1. Rate  
of 
increasing 
intraabdominal 
pressure  
  
Chi-squared   
Test  
/dichotomous  
-Type 1 error : 0.05  
-Power 0.8  
-Po ( control subject):  0.6 base on previous study by
Dubois et al.13  
-P1 ( study subject) : 0.9 base on previous study dubois
et. all  
-We are planning a study of independent cases and
controls with 1 control(s) per case.  
-We will need to study 32 experimental subjects and  
32 control subjects to be able to reject the null 
hypothesis that the failure rates for experimental and 
control subjects are equal with probability (power) 
0.8.   The Type I error probability associated with this 
test of this null hypothesis is 0.05.  We will use an 
uncorrected chi-squared statistic to evaluate this null 
hypothesis.  
-With addition of 10% drop out, we need 70 sample to
evaluate null hypothesis.   
-Software: power sample size calculation size app.  
2. Surgical space 
quality  
  
t.test  
-Type I error = 0.05  
-Power = 0.8  
-True difference of surgical space quality between 
group Moderate (control) and deep group is  0.5 base 
on previous study18  
-Standard deviation of surgical space quality is 0.4 on
a prior study18  
-Ratio of control to experimental patients = 1:1 -If the 
true difference in the experimental and control means 
is 0.5, we will need to study 11 experimental subjects 
and 11 control subjects to be able to reject the null 
hypothesis that the population means of the 
experimental and control groups are equal with 
probability (power) 0.8.   The Type I error probability 
associated with this test of this null hypothesis is 0.05. 
-Include 10% drop out we need 24 subjects to reject 
null hypothesis  
-Software: PS – Power and Sample Size Calculation  
3. Sacral 
promontory 
distance  
T test  
-Type I error = 0.05  
-Power = 0.8  

Page 12 of 48   
 
 
-True difference of sacral promontory distance 
between group Moderate (control) and deep group is 
0.38 base on previous study.22  
-Standard deviation of surgical space quality is 0.5
base on a prior study22  
-Ratio of control to experimental patients = 1:1  
-In a previous study the response within each subject 
group was normally distributed with standard 
deviation 0.5.  If the true difference in the 
experimental and control means is 0.38, we will need 
to study 28 experimental subjects and 28 control 
subjects to be able to reject the null hypothesis 22 -
Include 10% droup out . we need 62 sample to reject 
null hypothesis.  
-Software: PS – Power and Sample Size Calculation  
4,  
post-
operative pain   
  
T test  
-Type I error = 0.05  
-Power = 0.8  
-True difference of pain score between group 
Moderate (control) and deep group is 1 base on 
previous study.23  
-Standard deviation of surgical space quality is 1.4 on 
a prior study23  
-Ratio of control to experimental patients = 1:1  
- In a previous study the response within each subject 
group was normally distributed with standard 
deviation 1.4.  If the true difference in the 
experimental and control means is 1, we will need to 
study 32 experimental subjects and 32 control subjects 
to be able to reject the null hypothesis that the 
population means of the experimental and control 
groups are equal with probability (power) 0.8.   The 
Type I error probability associated with this test of this 
null hypothesis is 0.05.  
-Include 10% drop out. we need 70 sample to reject 
null hypothesis.  
-Software: PS – Power and Sample Size Calculation  
  
Objective 1 require highest sample to reject null hypothesis. To reject all the specific objective, 
the study needs 35 sample in moderate group and 35 sample in deep group to reject all the null 
hypothesis. Total 70 samples are required.  
  
  
  
  
  

Page 13 of 48   
  
10-Sampling method and subject recruitment  
• 
Approval from Ethics Committee of University Sains Malaysia (USM) health campus 
will be obtained prior to the recruitment of the patients.  
• 
Patient listed for elective laparoscopic gynaecological surgery, will be receive 1 day 
prior to operation day.  
• 
Potential adult patients will be selected according to inclusion and exclusion criteria 
one day before operation done by principal investigator.  
• 
Detailed explanation regarding study procedures will be explained and written inform 
consents will be obtained from patients by principal investigator one day before the 
operation.  
• 
The fasting time for all patients will be at least 6 hours prior to surgery   
• 
All consented patients will be randomly assigned into two group:   
Group 1 (Induction with rocuronium 0.6mg/kg + maintenance with ivi rocuronium rocuronium 
8-12mcg/kg/minute (0.48-0.72 mg/kg/hour maintain PTC 0-1(deep block). (Study Group)  
Group 2 (Induction with rocuronium 0.6mg/kg + maintenance with intermittent rocuronium 
0.2mg/kg  bolus. maintain PTC >1, TOF 0-2). Moderate block. (Control Group)  
• 
In operation room, baseline measurement of non-invasive blood pressure, mean arterial 
pressure, heart rate, pulse oximeter, electrocardiogram and oxygen saturation will be 
monitored at time T0  
• 
Prior to induction of anaesthesia, patients should have intravenous cannula inserted and 
either 0.9% sodium chloride or Ringer's lactate solution will commence.  
• 
General anaesthesia will commence to both group with bolus intravenous fentanyl 
100mcg, intravenous propofol 2mg/kg, intravenous rocuronium 0.6mg/kg as induction 
agent. Then intubate with PVC endotracheal tube.   
• 
Neuromuscular monitoring at ulnar nerve will be attached to both groups using TOF 
watch, intubation at TOF 0  
• 
Anaesthesia is maintained with inhalational anaesthetic agent at minimum alveolar 
concentration (MAC 1.0)  
• 
Surgical team is blind to the medication. Unblind investigator is responsible for drug 
administration and neuromuscular monitoring  
• 
Group 1 (Induction with rocuronium 0.6mg/kg + maintenance with intravenous 
infusion rocuronium ivi rocuronium 8-12mcg/kg/minute (0.48-0.72 mg/kg/hour  .  
maintain PTC 0-1)  

Page 14 of 48   
• 
Group 2 Induction with rocuronium 0.6mg/kg + maintenance with intermittent 
rocuronium bolus. maintain PTC >1, TOF 0-2)  
• 
Pneumoperitoneum is created initial at 8mmHg  
• 
Intravenous paracetamol 1g given after induction, and intravenous morphine 0.05mg/kg 
given   
• 
After the insertion of trocha, intraabdominal pressure is set at 8mmHg.  Skin sacral 
promontory distance is measured with the laparoscopic grasper through the trocha 
which inserted infraumbilically in 25 degree Trendelenburg position . A sterile ruler 
will be use to measure the distance from surgeon’s mark to the end of grasper in 
centimetres.   
• 
After the measurement , surgical procedure will continue as usual with intraabdominal 
pressure 8mmHg.  
• 
There surgeon are allowed to to change IAP to 12mmhg if they decide that visual field 
is inadequate for the operation.   
• 
At the end of surgery, infusion drug will discontinue, and neuromuscular drug will be 
reverse with Suggamadex base on TOF count for both group.   
• 
At the end of operation, surgeon will rated the surgical condition at 4 point scale ( 1= 
excellent, 2= good, 3=acceptable, 4= poor)  
• 
Intravenous dexamethasone 4mg will be given after induction, and intravenous 
ondansetron will be given 30 minute after the end of surgery for anti emetic.  
• 
The entire laparoscopic surgery and intra-abdominal pressure levels will be recorded to 
enable any subsequent analysis if necessary.   
• 
Post operatively at Post anaesthesia care unit, post op pain and shoulder tip pain will be 
evaluated at 30 minute and 24 hour Post operatively. Fentanyl is injected intravenously 
as needed in post anaesthesia care unit and dose will be recorded)   
• 
Pain will be measured using an 11-point numerical rating scale (NRS), ranging from 0 
(no pain) to 10 (most pain imaginable).  
• 
Postoperatively patient will be monitor at recovery bay operation theatre for at least 30 
minutes before discharge as standard post-operative monitoring before discharge to 
ward. Patient will be monitor with continuous vital sign monitoring similar to standard 
post-operative procedure.   
• 
The intubation procedure, anaethesia conduct and extubation procedure stated is similar  
using standard procedure as normal general anaesthesia is deliver to patient.  11- 
 

Page 15 of 48   
Operational definition  
Moderate and deep neuromuscular block  
Neuromuscular monitoring will be placed on patient ulnar nerve.   
  
Table from: Joaquín Fabregat López, César Augusto Candia Arana, Caridad Greta Castillo 
Monzón, Neuromuscular monitoring and its importance in the use of neuromuscular 
blockers,Colombian Journal of Anesthesiology, Volume 40, Issue 4, November – December 
2012, Pages 293-303.  
Moderate block define as train of four ( TOF) 0-2and Post tetanic count (PTC) > 1 whereas 
Deep block define as TOF 0 and  PTC 0-1)  
Low pressure pneumoperitoneum is defined as intraabdominal pressure 8mmHg. Rate of 
increasing intraabdominal pressure define as rate of conversion of intraabdominal pressure 
from 8mmHg to 12mmhg  
Quality of surgical space condition define as 1: excellent , 2: good but not optimum, 3: poor 
but acceptable, 4: unacceptable 13  
Pain score describe as ;  
  
  
  
  
  
  

Page 16 of 48   
12-  Data collection method, research tools and data analysis  
  
A- Data collection   
Data collection shall be done by the primary investigator using assessment form. The 
details to be filled in the form include patient general demographic data (age, gender, 
weight), surgical procedure,  airway details (number of intubation attempts, intubation 
condition scoring, time of surgery, skin sacral promontory distance, surgical condition 
score, pain at 30 minute and 24 hour and fentanyl requirement. Haemodynamic response 
also recorded  
B- Research tool and Data analysis  
Data will be entered and analysed using SPSS version 22. Descriptive statistics will be used 
to summarise the socio-demographic characteristics of subjects. Numerical data will be 
presented as mean (SD) or median (IQR) based on their normality distribution. Categorical 
data will be presented as frequency (percentage). Paired sample t test will be use compare 
continous variable where chi square test will be used to test proportion. our first objective 
will be analyze using chi square test. Where other objective will be test using student t test.  
C- Expected result(s)  
Patient demographic data   
  
Moderate block  
(n=35)  
Deep  
(n=35)  
block  
P  
Age (y)  
  
  
  
Weight (kg)  
  
  
  
Height(cm)  
  
  
  
BMI (Kg/m)  
  
  
  
ASA 1/2  
  
  
  
Previous 
abdominal 
surgery (yes/no)  
  
  
  
  
  
  

Page 17 of 48   
  
OBJECTIVE1: RATE OF INCREASING INTRAABDOMINAL PRESSURE  
  
Moderate ( 
n=35)  
Deep 
(n=35)  
P  
Increase  
of 
Intraabdominal 
pressure ( %)  
  
  
  
Operation  
time 
(min)  
  
  
  
Anaesthesia 
time(min)  
  
  
  
  
OBJECTIVE 2: SURGICAL CONDITION SCORE  
  
Figure 1: The distribution of 4 point surgical condition score  
  
OBJECTIVE 3 : SKIN-SACRAL PROMONTORY DISTANCE  
  
 
deep block 
moderate 
block 
  
0 
10 
20 
30 
40 
50 
moderate block 
deep block 
11 
11.5 
12 
12.5 
13 
13.5 
14 
pneumoperitoneum 
8 mmhg 

Page 18 of 48   
Figure 2 comparison of Mean skin sacral promotary distanceat moderate and deep 
block  
  
OBJECTIVE 4 : POST OPERATIVE VARIABLE . VALUE AREA MEANS, MEDIAN  
OR NUMBER  
  
Moderate block  
(n=35)  
Deep  
(n=35)  
block  
P  
Post 
operative 
pain ( 30minute)  
  
  
  
Post 
operative 
shoulder tip  
pain ( 30minute)  
  
  
  
Post 
operative 
pain (24H)  
  
  
  
Post 
operative 
shoulder tip  
pain (24 hour)  
  
  
  
Fentanyl 
requirement at 
recovery (µg)  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

Page 19 of 48   
D- DATA COLLECTION FORM  
 
3. surgical condition scale  
Study Id:       
Age:     years        month             Gender:   M/ F              
Ethnicity:  M / C  / I / Others  
Weight:    
Height:     
ASA : I/ II  (If ASA II, state the disease/s:                                              
Evaluation of pain score at PACU  
  
Diagnosis:  
Surgical procedure:  
Previous abdominal sugery: ( yes/ no)  
Anaesthetist’s year of experience: 
Surgeon years of experience:  <5 
years   5-10 years    > 10 years 
Surgery: start :               ends:  
Anaesthesia start:          ends:  
Group:   
1.Skin sacral promontory distance- ____ (cm)  
2. Surgery completed with intraabdominal pressure 
8mmHg ( Yes/ No)  
If no Time increasing Intraabdominal Pressure  
___H  
3.Highest intraabdominal pressure use___ (mmhg) 
 
  
  
Total fentanyl requirement in recovery =___mcg  
  
  
Pain 
score  
Shoulder 
tip pain 
score  
MAP  
HR  
Arrived  
at  
PACU  
T0    
  
  
  
30 
minute  
T3    
  
  
  
Evaluation of pain score in Ward  
  
pain 
score  
Shoulder 
tip pain 
score  
MAP   
HR  
24  
Hour  
  
  
  
  
DATA COLLECTION FORM : Evaluation of 
surgical 
condition 
during 
laparoscopic 
gynaecological surgery in patient with moderate 
vs deep neuromuscular block in lower pressure 
pneumoperitoneum.  
  
Surgical 
condition 
scale (tick 1 only)  
1= excellent  
  
2=good  
but  
optimal  
not    
3=poor 
acceptable  
but    
4=unacceptable  
  

Page 20 of 48   
 
13 - STUDY FLOW CHART  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 patients will be enrolled in the study:  
70 
 
   35 group 1 (deep block PTC  0 - 1)  
35 in group 2 (moderate block  PTC >1, TOF 0 - 
2 )  
Induction anesthesia:  
•  both group with intravenous fentanyl 100mcg,   
•  intravenous propofol 2mg/kg,   
•  intravenous rocuronium 0.6mg/kg.   
Maintenance of anaesthesia:  
•  Anaesthesia is maintained with inhalational anaesthetic agent at minimum alveolar concentration (MAC  
1.0)  
•  Group 1  - maintenance with ivi rocuronium  ivi rocuronium 8 - 
(0.48 
mcg/kg/minute  
12 
- 
mg/kg/hour. 
0.72 
 
maintain PTC 0 - 1)  
•  Group 2  - maintenance with intermittent rocuronium bolus o.2 mg/kg. maintain PTC >1, TOF 0 - 2)  
Analgesia: IV PCM1g   ,  IV morphine  
mg/kg 
0.05 
 
Anti emetic:  IV dexamethasone after induction, in ondansetron 4mg 30 minute before operation finish  
Intra - opera tively  
•  After the insertion of trocha, intraabdominal pressure is set at 8mmHg.  Skin sacral promontory distance  
is measured with the laparoscopic grasper through the trocha which inserted infraumbilically in 25 degree  
Trendelenburg position . A sterile ruler will  be use to measure the distance from surgeon’s mark to the  
end of grasper in centimetres.   
•  After the measurement , surgical procedure will continue as usual with intraabdominal pressure 8mmHg.  
•  There surgeon are allowed to to change IAP to 12mmhg if they de cide that visual field is inadequate for  
the operation.   
•  At the end of surgery, infusion drug will discontinue, and neuromuscular drug will be reverse with  
Suggamadex base on TOF count for both group.   
•  At the end of operation, surgeon will rated the surgical condition at 4 point scale ( 1= excellent, 2= good,  
3= acceptable, 4= poor)  
•  Intravenous dexamethasone 4mg will be given after induction, and intravenous ondansetron will be given  
30 minute after the end of surgery for anti emetic.  
•  The entire laparoscopic surgery and intra - abdominal pressure levels will be reco rded to enable any  
subsequent analysis if necessary.   
•  Post operatively at Post anaesthesia care unit, post op pain  and shoulder tip pain  will be evaluated at 30  
minute and 24 hour Post operatively. Fentanyl is injected intravenously as needed in post anaes thesia care  
unit and dose will be recorded)   

Page 21 of 48   
  
 
  
Dissertation write up and submission  
  
 
Data entry and analysis  

Page 22 of 48   
 
  
  
  

Page 23 of 48   
14- Gantt chart & milestone  
  
  
15- Ethical consideration(s) [if applicable]:  
  
The study will be conducted after obtaining ethics approval from Medical Research and Ethics 
Committee of University Sains Malaysia Health Campus.  
  
A.Subject vulnerability:  
  
- 
Potential study subjects are of ASA class I or II, who are not critically ill and require 
nonemergent, non-life saving surgeries whereby there is adequate time for patients counselling 
and study information. Study information and consent will be acquired during pre-operative 
round one day before operation. The potential subject is free to decide either to participate or 
not in the study after listen to all the explanation about the study. The patient schedule operation 
will be carried out as plan with all the standard procedure even the patient refuse to participate 
in the study.   
- 
The study drug, sugammadex is proved to be saved in reversing deep neuromuscular 
block - The study drug is not administered for life saving or disease modifying purpose.  
- 
Full information and the potential adverse effects of operation and study drug should 
be revealed.  
  

Page 24 of 48   
- 
the study will be stopped immediately in case of adverse events and necessary treatment 
will be given.  
-The investigator shall be blinded during the conduct of the study to eliminate potential bias 
and vulnerability issue. The investigator is investigator only, the other certified doctor will 
attend and conduct the case.   
  
B. Declaration of absence of conflict of interest  
- There is no conflict of interest in this study.  
  
C. Privacy and Confidentiality  
  
- Data obtained from this study did not identify the patient individually.  
-The patient is ensured of full privacy and confidentiality and no personal information shall be 
revealed to other individuals except the investigators.  
-Confidentiality shall only be broken if the study subject is suspected to have been 
harmeddirectly or indirectly by the study.  
  
D. Community sensitivities and benefits  
  
-Study drug and study procedures are provided at no cost to the patients involve.  
-The potential benefit of the study includes reduce the side effect of pneumoperitoneum to 
cardiorespiratory system, reduce pain, and reduce patient satisfaction in the surgery.  
  
E. Honorarium and incentives  
  
-The participation in this study is entirely voluntary.  
-There is no any kind of honorarium will be given to the subjects   
- Patient may choose to withdraw patient from the study at any point without penalty or loss of 
benefits.  

Page 25 of 48   
16- References  
1. Fabio Ghezzi, Stefano Uccella, Antonella Cromi, Gabriele Siesto, Maurizio Serati, 
Giorgio Bogani, Pierfrancesco Bolis, Postoperative pain after laparoscopic and vaginal 
hysterectomy for benign gynecologic disease: a randomized trial,American Journal of 
Obstetrics and Gynecology,Volume 203, Issue 2,2010,Pages 118.e1-118.e8,ISSN 
0002-9378,  
2. Madsen MV, Istre O, Staehr-Rye AK, et al.  Postoperative shoulder pain after 
laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure 
pneumoperitoneum: a randomised controlled trial. Eur J Anaesthesiol 2016; 33: 341–7  
3. KS G, JV, BR D. Low pressure versus standard pressure pneumoperitoneum in 
laparoscopic cholecystectomy. Cochrane Database Syst Rev 2014;3:1–6.  
4. Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to 
decrease laparoscopy‐induced shoulder and upper abdominal pain: a randomized 
controlled study. Arch Surg 2011; 146: 1360–1366.  
5. Giorgio Bogani, Stefano Uccella, Antonella Cromi, Maurizio Serati, Jvan Casarin, Ciro 
Pinelli, Fabio Ghezzi,Low vs Standard Pneumoperitoneum Pressure During  
Laparoscopic Hysterectomy: Prospective Randomized Trial,Journal of Minimally 
Invasive Gynecology,Volume 21, Issue 3,2014,Pages 466-471, ISSN 1553-4650,  
6. Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs standard 
pressures in gynecologic laparoscopy: a systematic review. JSLS 2016; 20: 
e2015.00113  
7. Donatsky AM, Bjerrum F, Gögenur I. Surgical techniques to minimize shoulder pain 
after laparoscopic cholecystectomy. A systematic review. Surg Endosc 2013; 27: 2275– 
2282.  
8. Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs standard 
pressures in gynecologic laparoscopy: a systematic review. JSLS 2016; 20: 
e2015.00113  
9. Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining optimal surgical conditions 
with low insufflation pressures is possible with deep neuromuscular blockade during 
laparoscopic colorectal surgery: a prospective, randomized, double-blind, parallelgroup 
clinical trial. Medicine 2016; 95: e2920  
10. Koo, B., Oh, A., Seo, K. et al. Randomized Clinical Trial of Moderate Versus Deep  
Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic  
Cholecystectomy.  
World  J  
Surg  40,  
2898–2903  
(2016). 
https://doi.org/10.1007/s00268-016-3633-8  
11. Madsen, M.V., Gätke, M.R., Springborg, H.H., Rosenberg, J., Lund, J. And ISTRE, O. 
(2015), Optimised laparoscopic space. Acta Anaesthesiol Scand, 59: 441-447. 
doi:10.1111/aas.12493  

Page 26 of 48   
12. Özdemir-van Brunschot, D.M.D., Braat, A.E., van der Jagt, M.F.P. et al. Deep 
neuromuscular blockade improves surgical conditions during low-pressure 
pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc 32, 245–251 (2018). 
https://doi.org/10.1007/s00464-017-5670-2  
13. Dubois, Philippe E.; Putz, Laurie; Jamart, Jacques; Marotta, Maria-Laura; Gourdin, 
Maximilien; Donnez, Olivier Deep neuromuscular block improves surgical conditions 
during laparoscopic hysterectomy: A randomised controlled trial, European Journal of 
Anaesthesiology: August 2014 - Volume 31 - Issue 8 - p 430-436 doi: 
10.1097/EJA.0000000000000094  
14. Madsen, Matias V.; Istre, Olav; Staehr-Rye, Anne K.; Springborg, Henrik H.; 
Rosenberg, Jacob; Lund, Jørgen; Gätke, Mona R. Postoperative shoulder pain after 
laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure 
pneumoperitoneum, European Journal of Anaesthesiology (EJA): May 2016 - Volume 
33 - Issue 5 - p 341-347 doi: 10.1097/EJA.0000000000000360  
15. M. H. Bruintjes, E. V. van Helden, A. E. Braat, A. Dahan, G. J. Scheffer, C. J. van 
Laarhoven, M. C. Warlé, Deep neuromuscular block to optimize surgical space 
conditions during laparoscopic surgery: a systematic review and meta-analysis, BJA: 
British Journal of Anaesthesia, Volume 118, Issue 6, June 2017, Pages 834–842, 
https://doi.org/10.1093/bja/aex116  
16. Park, Sun-Kyung; Son, Young G.; Yoo, Seokha; Lim, Taeyoon; Kim, Won Ho; Kim, 
Jin-Tae Deep vs. moderate neuromuscular blockade during laparoscopic surgery,  
European Journal of Anaesthesiology: November 2018 - Volume 35 - Issue 11 - p 867- 
875 doi: 10.1097/EJA.0000000000000884  
17. Wei, Yiyong PhDa,b; Li, Jiaa,b; Sun, Fudec; Zhang, Donghanga,b; Li, Minga,b; Zuo, 
Yunxiaa,b,
 Low intra-abdominal pressure and deep neuromuscular blockade 
laparoscopic surgery and surgical space conditions, Medicine: February 2020 - Volume 
99 - Issue 9 - p e19323 doi: 10.1097/MD.0000000000019323  
18. Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions 
during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br 
J Anaesth 2014; 112: 498–505  
19. Staehr-Rye AK, Rasmussen LS, Rosenberg J, et al.  Surgical space conditions during 
low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular 
blockade: a randomized clinical study. Anesth Analg 2014; 119: 1084–92  
20. Yoo YC, Kim NY, Shin S, et al.  The intraocular pressure under deep versus moderate 
neuromuscular blockade during low-pressure robot assisted laparoscopic radical 
prostatectomy in a randomized trial. PLoS One 2015; 10: e0135412  
21. Blobner M, Frick CG, Stäuble RB, et al.  Neuromuscular blockade improves surgical 
conditions (NISCO). Surg Endosc 2015; 29: 627–36 laparoscopy – a randomised, 
blinded crossover study. Acta Anaesthesiol Scand 2015; 59: 441–710.    

Page 27 of 48   
22. Barrio J, Errando CL, San Miguel G, et al.  Effect of depth of neuromuscular blockade 
on the abdominal space during pneumoperitoneum establishment in laparoscopic 
surgery. J Clin Anesth 2016; 34: 197–203  
23. Torensma B, Martini CH, Boon M, et al.  Deep neuromuscular block improves surgical 
conditions during bariatric surgery and reduces postoperative pain: a randomized 
double blind controlled trial. PLoS One 2016; 11: e0167907  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  

Page 28 of 48   
RESEARCH INFORMATION  
Research title:   
Research title: Evaluation of surgical condition during laparoscopic 
gynaecological surgery in patient with moderate vs deep 
neuromuscular block in lower pressure pneumoperitoneum.  
Principal investigator :  
Dr Umairah Binti Esa ( MMC 71514)  
Associate Prof Dr Rhendra Hardy B Mohamad Zaini 
(MMC 32241, NSR 126684 ).  
Dr Zulfakar Mazlan (MMC 46464, NSR: 132658)  Dr 
Sanihah Che Omar [ MMC44833, NSR 132654] Dr Ahmad 
Akram Omar (MMC 46516, NSR 130133)  
  
INTRODUCTION  
Your are invited to participate in a voluntary research study on general anesthesia in 
laparoscopic surgery using the use of muscle relaxants at two different levels, both deep and 
moderate at low abdominal pressure during operation.  
Before you participate in this study, it is important that you read and understand this research 
information. If you agree to participate in this study, you will receive a copy of this form for 
your records.  
Your participation in this study is expected to take up to 24 hours after surgery. A total of 70 
patients participated in this study. Your participation in this study is expected to last up to 24 
hour after the completion of surgery. Up to 70 patients will be participating in this study.   
  
PURPOSE OF THE STUDY  
1. primary outcome variable was the rate of increasing intra-abdominal pressure (IAP) by 
the surgeon when they decided that the surgical conditions were inadequate for the 
operation in patient receiving deep and moderate neuromuscular block in laparoscopic 
gynaecological surgery.  
2. To compare quality of surgical space condition in patient receiving deep and moderate 
neuromuscular block in laparoscopic gynaecological surgery.  
  
3. To compare skin to sacral promontory distance in patient in patient receiving moderate 
neuromuscular block and deep neuromuscular block in laparoscopic gynaecological 
surgery.  
4. To compare the post-operative pain and shoulder tip pain in patient receiving deep 
neuromuscular block and moderate neuromuscular block in laparoscopic 
gynaecological surgery  
  

Page 29 of 48   
QUALIFICATION TO PARTICIPATE  
The doctor in charge of this study or a member of the study staff have discussed with you the 
requirements for participation in this study. It is important that you are completely truthful with 
the doctor about your health history. You should not participate in this study if you do not meet 
all qualifications. You have your right to refuse to participate or to participate after listen to the 
procedure and study protocol. Your operation will still be carried out as plan if you refuse to 
participate in this study.  
The requirements to be in this study are:  
1. Age more than 18 years old   
2. ASA I or II  
3. schedule to undergo laparoscopic gynaecological surgery (laparoscopic hysterectomy 
and laparoscopic ovarian cystectomy in Hospital University Sains Malaysia , Kubang 
Kerian, Kelantan  
  
Your cannot participate in this study if:  
1. Allergy to study drugs (rocuronium, suggamadex)  
2. Serious cardiac and respiratory disease (reactive airway disease, upper respiratory tract 
infection)  
3. Neurological or neuromuscular disease (epilepsy, family history and history of 
malignant hyperthermia etc.)  
4. Pregnancy  
5. Morbid obesity BMI>35  
  
STUDY PROCEDURE  
Before the surgery, during premedication round we will tell you about this study. You will be 
asked to provide information about your medical history including all health problems, medical 
and surgical history, and any medications taken. You will also undergo a physical examination 
to ensure the suitability of this study.  
After obtaining your consent, in the operating room, you will first be equipped with measuring 
and reading blood pressure, heart rate, heart rate, oxygen levels in the blood and levels of 
consciousness. This tool will record important readings throughout the anesthesia and surgery. 
Installation of these tools is a routine for all patients undergo anaethesia and surgery and you 
will be given general anesthesia on the day of surgery. Then you will receive standard general 
anesthesia like other surgical procedures. You will then be randomly assigned to one group, 
where one group will receive a moderate neuromuscular block, while another group will 
receive a deep neuromuscular block. This randomization is made using computer software.  

Page 30 of 48   
Neuromuscular blockage is routine procedure during anaesthesia. Neuromuscular block is 
given to patient after the patient asleep under general anaethesia. In this study, neuromuscular 
block will be given in either deep neuromuscular block or moderate neuromuscular block and 
it will be strictly monitored with neuromuscular monitoring device. Deep neuromuscular block 
will cause the muscle to fully relax without contraction. After the operation finished 
neuromuscular blockade will be reverse by suggamadex. This medication is safe. The adverse 
event include allergic reaction and inadequate reversal but it is very rare.  
Once the surgery is concluded, you will then be placed in the recovery area within the Operating 
Theater. You will be monitored for possible side effects of the study drug prior to transfer back 
to ward.  
  
RISKS AND COMPLICATIONS  
There are certain risks imposed to you with your participation in this research. Side effects that 
can occur including reduction in blood pressure and slow the heart rate, and risk of inadequate 
reversal cause breathing problems. Risk of deep neuromuscular blockage include inadequate 
reversal post operatively and there is a risk of shortness of breath. However this risk has been 
reduce by using neuromuscular monitoring and sugammadex. The endotracheal tube will only 
be removed after your muscle function recover completely. Risk of laparoscopic surgery 
include post operative nausea, vomiting, abdominal pain and shoulder tip pain.   
Your will be closely monitored for occurrence of these side effects throughout the surgery and 
in recovery area post-surgery and will be promptly treated if present.  
If any new information is found from this research which may affect your heath, you will be 
promptly notified.  
Your safety is our priorities  
  
REPORTING HEALTH EXPERIENCES  
If you has any injury, adverse effects, or any unusual health experience(s) during this research, 
please inform immediately the nurse in charge or Dr. Umairah Esa (MMC Registration No. 
71514) at 013-7517305. You can call at any time, day or night to report such health 
experience(s).  
  
PARTICIPATION IN THE STUDY  
Your participations in this research is entirely voluntary. You have the right to refuse 
participating in this research at any time, without any penalty or loss of benefits entitled to you. 
Your schedule operation will be going on as plan even if you refuse to participate in the 
research.   

Page 31 of 48   
Your participation may also be stopped by the doctor in charge without your consent. If your 
were withdrawn from the research, the doctor in charge or personnel involve in the research 
will discuss with you regarding any possible medical issues related to your withdrawal from 
the research.   
It will not involve any follow-up visit once you is discharged home  
POTENTIAL BENEFITS  
This drug used and procedures involved in this research will be provided to you at no cost. The 
outcome and information gained from this research may be beneficial to future patients. You 
will not receive any compensation for joining this research.  
  
ENQUIRIES  
If you have any enquiry about this research or on your rights as a participant, please contact:  
Dr. Umairah binti Esa [MMC: 71514]  
Jabatan Anaestesiologi dan Rawatan Rapi  
USM Kampus Kesihatna   
Tel. no: 013-7517305  
Email: umairahesa@usm.my  
  
ATAU  
  
Assoc Prof Dr Rhendra Hardy Mohamad Zaini [MPM: 32241]  
Dr zulfakar Mazlan [MMC 46464]  
Dr Sanihah Che Omar [ MMC44833]  
Jabatan Anaestesiologi dan Rawatan Rapi  
Dr Ahmad Akram Omar (MMC 46516, NSR 130133)  
Jabatan Obstetri dan Gynaecology  
USM Kampus Kesihatan  
Email: rhendra@gmail.com/ zulfakar@usm.my/ sanihah_che@usm.my  
  
If you have any questions regarding the Ethical Approval or any issue/problem related to this 
study, please contact;  
En. Mohd Bazlan Hafidz Mukrim  
Human Research Ethics Committee USM 
Division of Research &Innovation (P&I) 
USM Kampus Kesihatan.  
No Tel: 09-7672354/ 09-7672362  
Email: bazlan@usm.my/jepem@usm.my  
   
  
  
  
  
  
  
  
  
  
  
        OR  
Miss Nor Amira Khurshid Ahmed  

Page 32 of 48   
                              Secretariat of Human Research Ethics Committee USM Research 
Creativity & Management Office (RCMO)      USM Main Campus, Penang                      
Tel. No. : 04-6536537                Email : noramira@usm.my CONFIDENTIALITY  
  
Your medical information will be kept confidential by the research team. It will not be made 
publicity available unless its discussion is required by the law.  
Data obtained from this research which does not identify you individually may be published 
for academic purposes.  
Your original medical records may be reviewed by researcher, the Ethical Review Board for 
this research, and regulatory authorities for the purpose of verifying clinical trial procedures 
and / or clinical research data. Your medical records may be kept in and processed in a 
computer.  
By signing this consent form, you authorize the record review, information storage and data 
transfer as describe above.  
  
SIGNATURES  
If you agree to take part in this research, you must sign the signature page  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
  
  

Page 33 of 48   
Patient  Information and Consent Form 
(Signature Page)  
 
  
Research Title:  Evaluation of surgical condition during laparoscopic gynaecological surgery 
in patient with moderate vs deep neuromuscular block in lower pressure 
pneumoperitoneum.  
  
Principal investigator : Dr Umairah Binti Esa ( MMC 71514)  
Associate Prof Dr Rhendra Hardy B Mohamad Zaini (MMC 
32241, NSR 126684 ).  
Dr Zulfakar Mazlan (MMC 46464, NSR: 132658) Dr Sanihah Che 
Omar [ MMC44833, NSR 132654] Dr Ahmad Akram Omar (MMC 
46516, NSR 130133)  
  
To become a part this study, you or your legal representative must sign this page. By signing this page, 
I am confirming the following:  
  
• 
I have read all of the information in this Parents/Guardian Information and Consent Form 
including any information regarding the risk in this study and I have had time to think 
about it.  
• 
All of my questions have been answered to my satisfaction.  
• 
I voluntarily agree my child to be part of this research study, to follow the study procedures, 
and to provide necessary information to the doctor, nurses, or other staff members, as 
requested.  
• 
I may freely choose to stop being a part of this study at any time.  
• 
I have received a copy of this Parental/Guardian Information and Consent Form to keep 
for myself.  
  
___________________________________________                    
 
Patient’s/Guardian’s Name                           
  
                
  
  
 
 
Patient’s/Guardian’s  I.C No. (New)  
  
                          
  
 
 
 
Signature of Patients/Guardian’s  
  
                 
  Date (dd/MM/yy)  
                                                                                                 
                                                                                                 
 
Name and Signature of Individual                                                    Date (dd/MM/yy)  
Conducting Consent Discussion                                                                                   
  
  
  
                                  
Name & signature of Witness                                                             Date (dd/MM/yy)         
  
Note:  i) All subjects/patients who are involved in this study will not be covered by insurance.    

P a g e 3 4  of 4 8    
                                     P arti ci p a nt’ s M at eri al P u bli c ati o n C o n s e nt F or m  
Si g n at ur e P a g e  
 
 
R e s e ar c h Titl e:   E v al u ati o n of s ur gi c al c o n diti o n d uri n g l a p ar o s c o pi c g y n a e c ol o gi c al s ur g er y i n 
p ati e nt  wit h  m o d er at e  v s  d e e p  n e ur o m u s c ul ar  bl o c k  i n  l o w er  
pr e s s ur e p n e u m o p erit o n e u m.  
  
Pri n ci p al i n v e sti g at or :   
 D R U M AI R A H BI N TI E S A ( M M C 7 1 5 1 4)  
C o -r e s e ar c h er s:   
A S S O CI A T E P R O F D R R H E N D R A H A R D Y B M O H A M A D Z AI NI  
( M M C 3 2 2 4 1, N S R 1 2 6 6 8 4 ).  
D R Z U L F A K A R M A Z L A N ( M M C 4 6 4 6 4, N S R: 1 3 2 6 5 8)  
D R S A NI H A H C H E O M A R [ M M C 4 4 8 3 3, N S R 1 3 2 6 5 4]  
D R A H M A D A K R A M O M A R ( M M C 4 6 5 1 6, N S R 1 3 0 1 3 3)  
  
  
T o b e c o m e a p art t hi s st u d y, y o u or y o ur l e g al r e pr e s e nt ati v e m u st si g n t hi s p a g e.  B y 
si g ni n g t hi s p a g e, I a m c o nfir mi n g t h e f oll o wi n g:   
  
� 
I u n d er st o o d t h at m y n a m e will n ot a p p e ar o n t h e m at eri al s p u bli s h e d a n d t h er e h a v e b e e n 
eff ort s  t o  m a k e  s ur e  t h at  t h e  pri v a c y  of  m y  n a m e  i s  k e pt  c o nfi d e nti al  alt h o u g h  t h e  
c o nfi d e nti alit y i s n ot c o m pl et el y g u ar a nt e e d d u e t o u n e x p e ct e d cir c u m st a n c e s.   
  
� 
I h a v e r e a d t h e m at eri al s or g e n er al d e s cri pti o n of w h at t h e m at eri al c o nt ai n s a n d r e vi e w e d 
all p h ot o gr a p h s a n d fi g ur e s i n w hi c h I a m i n cl u d e d  t h at c o ul d b e p u bli s h e d.   
  
� 
I h a v e b e e n off er e d t h e o p p ort u nit y t o r e a d t h e m a n u s cri pt a n d t o s e e all m at eri al s i n w hi c h 
I a m i n cl u d e d, b ut h a v e w ai v e d m y ri g ht t o d o s o.   
  
� 
All t h e p u bli s h e d m at eri al s will b e s h ar e d a m o n g t h e m e di c al pr a ctiti o n er s, s ci e nti st s a n d 
j o ur n ali st w orl d wi d e.  
  
� 
T h e m at eri al s will al s o b e u s e d i n l o c al p u bli c ati o n s, b o o k p u bli c ati o n s a n d a c c e s s e d b y 
m a n y l o c al a n d i nt er n ati o n al d o ct or s w orl d wi d e.   
  
� 
I h er e b y a gr e e a n d all o w t h e m at eri al s t o b e u s e d i n ot h er p u bli c ati o n s r e q uir e d b y ot h er 
p u bli s h er s wit h t h e s e c o n diti o n s:   
  
� 
T h e m at eri al s will n ot b e u s e d a s a d v erti s e m e nt p ur p o s e s n or a s p a c k a gi n g m at eri al s.   
  
� 
T h e m at eri al s will n ot b e u s e d o ut of c o n t e xt – i. e.: S a m pl e pi ct ur e s will n ot b e u s e d i n a n 
arti cl e w hi c h i s u nr el at e d s u bj e ct t o t h e pi ct ur e.   
  
  
 
 
P ati e nt’ s/ g u ar di a n n a m e   
   
 
P ati e ntt’ s/ G u ar di a n’ s  I. C N o. ( N e w)   
  
                       
  
 
 
Si g n at ur e of P ati e nt / G u ar di a n’ s   
                                     D at e ( d d/ M M/ y y)  

Page 35 of 48   
                                                                                                
 
 Name and signature of Individual  Conducting                          Date (dd/MM/yy)  
 Consent Discussion                                                               
  
Note:  i) All subjects/patients who are involved in this study will not be covered by insurance.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 36 of 48   
CURRICULUM VITAE                                                                             
  
1. Name: Dr. Umairah binti Esa                                                                    
  
2. I. C. No./Passport No.: 890301015108  
  
3. Work Address: Department of Anaesthesiology,  
   School of Medical Sciences,  
   Health Campus,  
   Universiti Sains Malaysia.,  
   16150 
Kubang 
Kerian,    
Kelantan  
      Tel. No: 0137517305  
      E-mail Address: umairahesa@usm.my   
4. Academic Qualifications and Brief Career History:  
  
Year  
Degree  
Discipline  
University  
 2008-2014  
Bachelor in Medicine and 
Bachelor in Surgery (MBBS)  
Medicine  
Universiti Sains Islam  
Malaysia  
2018-present  
(in training)  
Master in Medicine  
Anaesthesiology  Universiti Sains Malaysia  
  
Year  
Position  
Place of Work  
 2014-2017  
House Officer  
Hospital Sultanah Nora Ismail  
Jalan Korma, Taman Soga, 83000 Batu Pahat,  
Johor  
2017-2017  
Medical Officer  
Department of Anaesthesiology and Intensive 
Care,  
Hospital Melaka  
Jalan Mufti Haji Khalil 75400 Melaka  
2017-2018  
Medical officer  
Department of Anaesthesiology and Intesive Care, 
School of Medical Science, Health Campus  
Universiti Sains Malaysia  
2018-present  
Master Student  
Department of Anaesthesiology and Intesive Care, 
School of Medical Science, Health Campus  
Universiti Sains Malaysia  

Page 37 of 48   
CURRICULUM VITAE  
  
Name: Assoc. Prof. Rhendra Hardy Bin Mohamad Zaini   
     
  
  
  
  
  
  
   
2. I. C. No./Passport No:  701215-03-5358  
   
3. Work Address:     Department of Anaesthesiology   
         School of Medical Science, Health Campus,   
         Universiti Sains Malaysia,   
         16150 Kubang Kerian, Kelantan   
   
  
Tel. No: +6097676095   
 Fax No: +6097653370   
 Mobile Phone No: +60199106665   
 E-mail Address: rhendra@gmail.com  
   
4. Academic Qualifications and Brief Career History:   
Year  
Degree  
Discipline  
University  
1995  
Medical Degree  
Medicine  
USM  
2002  
Master in Medicine  
Anaesthesiology  
USM  
2005  
Fellowship  
Pain and Thoracic 
Anaesthesia  
Toranomon Hospital, 
Tokyo, Japan  
   
Year  
Position  
Place of work  
1995-1996  
House Officer  
Hospital Kota Bharu, Hospital Alor Setar  
1996-1998  
Medical Officer  
Dept of Anaesthesiology, USM  
2000-2002  
Trainee Lecturer  
Dept of Anaesthesiology, PPSP, USM  
2002-present  
Lecturer & Anaesthesiologist  
Dept of Anaesthesiology, PPSP, USM  
5.Field(s) of Specialization: Airway management  
  
6.Research area:  
• 
Airway management  
• 
Regional anaesthesia  
• 
Nutrition in ICU  
  
7. Grants in the Last 5 Years:   
  
1. Comparing the Effectiveness Between Air-Q Intubating Laryngeal Airway and Ambu® 
AuraGain™ Laryngeal Mask as a Conduit for Endotracheal Intubation in Simulated Cervical 
Spine Injury in Adult.   
  
2. Comparative Study on Sustainable Monitoring During Total Intravenous Anaesthesia in              
Neurosurgery between Bispectral Index and Cerebral State Monitoring (2017-2019). Short              
term Grant, RM 37,440. Mohamad Hasyizan Bin Hassan, Rhendra Hardy Mohd Zaini,  
  
  
  
  

Page 38 of 48   
  
  
8. List NOT MORE than 10 Significant/Relevant/Related Journal Publications:  
  
1. Mohd Hasyizan H., Wan Mohd Nazaruddin W. H., Rhendra Hardy M. Z., Wan Fadzlina W. 
M. S., Huda Z. A., Chong S. E. Balanced Fluid Versus Saline-Based Fluid in Post-operative 
Severe Traumatic Brain Injury Patients: Acid-Base and Electrolytes Assessment. Malaysian 
Journal of Medical Sciences; 24(5): 83-93. Index in: Bioline International, SCOPUS, EBSCO, 
DOAJ, Index Copernicus, Google Scholar,MyAIS.2017, 24/5: 83-93.  
  
2. Wan Hassan WMN, Suut N, Tan PCH, Mohd Zaini RH. Balanced versus Saline-Based Fluid 
Regimen for Elective Supratentorial Craniotomy: Acid-Base and Electrolyte Changes. Middle 
East Journal of Anaesthesiology, Oct 2017, 24(3); 195-204. Index in: the Index Medicus and  
MEDLARS system, SCOPUS. ISSN 0544-0440  
  
3. Wan Hassan WMN, Mohd Nasir Y, Mohd Zaini RH, Wan Ahmad Shukeri WF. Target- 
controlled Infusion Propofol versus Sevoflurane Anaesthesia for Emergency Traumatic Brain 
Surgery: Comparison of the Outcomes. Malaysian Journal of Medical Sciences, 2017;  
24(2):73-82. Index in: Bioline International, SCOPUS, EBSCO, DOAJ, Index Copernicus, 
Google Scholar, MyAIS  
  
4. Wan Hassan WMN, Tan HS, Mohd Zaini RH. Comparison of the effects of dexmedetomidine 
on induction between using Marsh and Schnider pharmacokinetic models of propofol 
targetcontrolled infusion. Malaysian Journal of Medical Sciences Jan-Feb 2018, 25 (1): 24-31. 
Index in: Bioline International, SCOPUS, EBSCO, DOAJ, Index Copernicus, Google Scholar, 
MyAIS  
  
5. Mohamad Hasyizan Bin Hassan, Fung EM, Rhendra Hardy Mohd Zaini, Shamsul kamalrujan 
Hassan, S Praveena A/p Seevaunnamtum, Mohd Zulfakar Bin Mazlan A Comparison Between 
Measured Maxillopharyngeal Angle On Lateral Cervical Radiograph With Modified 
Mallampati Classification In Predicting Difficult Larnygoscopy : A Blinded Interventional 
Study. Malaysian Journal of Medicine and Health Science. 2018;14(2); 51-56. Indexed in: 
Scopus, EBSCOhost, ISC, and Rubriq  
  
6. Chong Soon Eu, Rhendra Hardy Mohd Zaini, Wan Fadzlina Binti Wan Muhd Shukeri, Al- 
jadidi Bin Sulaiman, Vivekananda Gunasekaran. Sugammadex Rescue in Avoiding Intensive 
Care       Unit Admission in an Octogenarian Undergoing Emergency Laparotomy. Journal of  
PeriAnesthesia Nursing, 2018; 33/5:, 727-731. Indexed in CINAHL and Scopus.(Impact Factor 
: 0.748)   
  
7. Mohd Zulfakar Bin Mazlan, Nik Abdullah Bin Nik Mohamad, Zeti Norfidiyati Binti 
Salmuna@ayub, Mohamad Hasyizan Bin Hassan, Saedah Binti Ali, W Mohd Nazaruddin Bin 
W Hassan, Laila Binti Ab Mukmin, Rhendra Hardy Mohd Zaini, Ariffin Marzuki Bin 
Mokhtar, Chandran A/l Nadarajan, Ahmad Zuhdi Bin Mamat, Alwi Bin Muhd Besari @ 
Hashim, Azian Binti Harun. A Fatal Case of Immunocompetent Aspergilloma: Bronchial 
Artery Embolization Fail to Halt Recurrent Hemoptysis. Current Respiratory Medicine 
Reviews, 2018, 14:1-3. Index in: Emerging Sources Citation Index (ESCI), Scopus, EMBASE, 
Chemical Abstracts Service/SciFinder, ProQuest, ChemWeb, Google Scholar, CINAHL®, 
EMNursing, PubsHub, Index Copernicus, Genamics JournalSeek, MediaFinder®-Standard  
Periodical Directory, J-Gate, CNKI Scholar, Suweco CZ, TOC Premier, EBSCO, Ulrich&#39;s 
Periodicals Directory and JournalTOCs. (Impact Factor : 0.13)   
  
8. Wan Mohd Nazaruddin Wan Hassan, Azelia Mansur, Rhendra Hardy Mohamad 
Zaini.Anaesthesia using target-controlled infusion of Propofol during pediatric surgery: Kataria 

Page 39 of 48   
versus Paedfussor pharmacokinetic. Anaesthesia, Pain and Intensive Care, 2018 22(2):207-211. 
Index in: Embase, EMCare,Index Medicus (EMR), Ulrich’s Directory (Switzerland), UDL 
(Malaysia), infomine – The Regents of the University of California, GFMER – Geneva, 
Foundation for Medical Education and Research, Index Pakistan of PM&amp;DC approved 
journals, EZB – Electronic Journals Library,JournalSeek, SCIRUS, I-Share , University of 
Newcastle, ISSN:1607-8322 (Print) ; 2220-5799 (Electronic) ; 1607-8322 (Linking)  
  
9. Wan Fadzlina Wan Muhd Shukeri, Mohd Hasyizan Hassan, Wan Mohd nazaruddin 
WanHassan, Rhendra hardy Mohamad Zaini. Anastomotic Leak after Bariatric Surgery from 
a Critical Care Perspective: A Lesson Shared. Malays J Med Sci.; 2018 25(5): 157–158.Index 
in: Bioline International, SCOPUS, EBSCO, DOAJ, Index Copernicus, Google Scholar, MyAIS  
  
10. Nirawanti Mohamad Said, Rhendra Hardy Mohd Zaini (*Corresponding author), W Mohd 
Nazaruddin Bin W Hassan, Mohamad Ibariyah Bin Iberahim, Chong Soon Eu. A Randomized 
Comparison of the Air-Q Intubating Laryngeal Airway and Ambu®AuraGain™ Laryngeal  
Mask for Controlled Ventilation in Children. Anaesthesia, Pain and Intensive Care, 2018 
(Accepted)  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

Page 40 of 48   
  
  
CURRICULUM VITAE  
  
1. Name: Dr Mohd Zulfakar bin Mazlan  
  
2. I. C. No./Passport No.:  821124145833  
  
3. Work Address:    
  
Department of Anaesthesiology   
School of Medical Science, Health Campus,   
Universiti Sains Malaysia,   
16150 Kubang Kerian, Kelantan   
  
  
Tel. No: 097676104  
  
Fax No: 097653350  
  
Mobile Phone No: 0129091447  
  
E-mail Address: zulfakar@usm.my, zulfakarmohd98@yahoo.com  
  
4. Academic Qualifications and Brief Career History:  
  
Year  
Degree  
Discipline  
University/Work Place  
2007   
2015  
MBBS (MPM 46464)  
MMed (NSR132658)  
Medical Doctor 
Anaesthesiology  
International Islamic 
University Malaysia  
Universiti Sains Malaysia  
  
5. Field(s) of Specialization: Anaesthesiology and Critical Care  
  
6. Research Area: Anaesthesiology and Critical Care  
  
7. Grants in the Last 5 Years: Short term USM grant 2016 as a Leader (PI at USM), FRGS  
2016 as a Co- Researcher (PI at USM site), PRGS 2018 as a Co- Researcher  
  
8. List NOT MORE than 10 Significant/Relevant/Related Journal Publications:   
  
1-Mohd Zulfakar Bin Mazlan, Shamsul Kamalrujan Hassan, Laila Binti Ab Mukmin, Mohamad  
Hasyizan Bin Hassan, Huda Binti Zainal Abidin, Irfan Bin Mohamad, Chandran A/l Nadarajan,  
Rubindetan Muthusamy, Chong Soon Eu, 2016, Novel Usage of Dexmetomidine In A  
Paediatric Patient With Giant Tongue Haemangioma,Malaysian Journal of Medicine and Health 
Sciences: , Impact Factor : 0.1  
  
2- Mohd Zulfakar Bin Mazlan, Rhendra Hardy Mohd Zaini, Shamsul Kamalrujan Hassan,  
Saedah Binti Ali, Sanihah Binti Che Omar, W Mohd Nazaruddin Bin W Hassan, 2017, 
Significance of a clean-tip catheter closed suctioning system in a high-setting ventilated, super 
morbidly obese patient with profuse respiratory secretions, Respiratory Medicine Case 
Reports, 21(2017)129-131:, (Impact Factor : 0.2)   
  
3- Mohd Zulfakar Bin Mazlan, Saedah Binti Ali, Huda Binti Zainal Abidin, Ariffin Marzuki Bin  
 

Page 41 of 48   
Mokhtar, Laila Binti Ab Mukmin, Zeti Norfidiyati Binti Salmuna@ayub, Chandran A/l  
Nadarajan, 2017, Non-invasive ventilation in a pregnancy with severe pneumonia, Respiratory 
Medicine Case Reports, : , (Impact Factor : 0.2)   
  
4- Zeti Norfidiyati Binti Salmuna@ayub, Habsah Bt Hasan, Zeehaida Mohamed, Alwi Bin  
Muhd Besari @ Hashim, Mohd Zulfakar Bin Mazlan, 2017, Frequent Relapse of Plasmodium  
vivax Infection: Case Report and Literature Review, Clinical Microbiology Newsletter, :, 165166 
(Impact Factor : 0.191)   
  
5- Chua Wei Chuan, Mohd Zulfakar Bin Mazlan, Saedah Binti Ali, Sanihah Binti Che Omar, W  
Mohd Nazaruddin Bin W Hassan, S Praveena A/p Seevaunnamtum, Rhendra Hardy Mohd  
Zaini, Mohamad Hasyizan Bin Hassan, ALWI M BESARI, Zaidah Bt Abdul Rahman, Zeti  
Norfidiyati Binti Salmuna@ayub, Nur Sabrina Binti Abdul Ghani, Normalinda Binti Yaacob, 
Wan Rosilawati Wan Rosli, 2017, Post-partum Streptococcal toxic shock syndrome 
associated with necrotizing fasciitis, ID Cases, :, (Impact Factor : 0.3)   
  
6- Nazhan Afeef Mohd Ariff, Mohd Zulfakar Bin Mazlan, Mohd Erham Bin Mat Hassan, S  
Praveena A/p Seevaunnamtum, Wan Fadzlina Binti Wan Muhd Shukeri, Nik Abdullah Bin Nik  
Mohamad, Shamsul Kamalrujan Hassan, Kamaruddin Jaalam, Mohamad Hasyizan Bin  
Hassan, Sanihah Binti Che Omar, Chandran A/l Nadarajan, Irfan Bin Mohamad, 2018, 
Undiagnosed chicken meat aspiration as a cause of difficult-to-ventilate in a boy with 
traumatic brain injury, Respiratory Medicine Case Reports, :, (Impact Factor : 0.2)   
  
7- Nurfatin Mohd Shah, Chong Soon Eu, Syahirah Mohamed Yusoff, Mohd Zulfakar Bin  
Mazlan, Khairul Bariah Binti Johan @rahmat, Nizuwan Bin Azman, Lim Jo Anne, Siti  
Mardhiana Binti Mohamad, Siti Salmah Bt Noordin, Zainab Binti Abdul Ghaffar, Mohamad 
Hasyizan Bin Hassan, Muhammad Azrul Bin Zabidi, Nur Arzuar Bin Abdul Rahim, 2018, 
Recombinant activated factor VII (rFVIIa) in refractory haemorrhage for non-haemophiliacs: 
an eleven-year single-centre experience, BMC Hematology, 18/34:, (Impact Factor : 0.54)  
  
8- Mohd Zulfakar Bin Mazlan, Nik Abdullah Bin Nik Mohamad, Zeti Norfidiyati  
Binti Salmuna@ayub, Mohamad Hasyizan Bin Hassan, Saedah Binti Ali, W Mohd Nazaruddin  
Bin W Hassan, Laila Binti Ab Mukmin, Rhendra Hardy Mohd Zaini, Ariffin Marzuki Bin  
Mokhtar, Chandran A/l Nadarajan, Ahmad Zuhdi Bin Mamat, Alwi Bin Muhd Besari @  
Hashim, Azian Binti Harun, 2018, A Fatal Case of Immunocompetent Aspergilloma: Bronchial  
Artery Embolization Fail to Halt Recurrent Hemoptysis, Current Respiratory Medicine  
Reviews,, 14,:, 1-3 (Impact Factor : 0.13)   
  
9-Mohamad Hasyizan Bin Hassan, Rhendra Hardy Mohd Zaini, Shamsul Kamalrujan Hassan,  
S Praveena A/p Seevaunnamtum, Mohd Zulfakar Bin Mazlan, Nik Abdullah Bin Nik  
Mohamad, 2018, A Comparison Between Measured Maxillopharyngeal Angle On Lateral  
Cervical Radiograph with Modified Mallampati Classification In Predicting Difficult  
Larnygoscopy: A Blinded Interventional Study, Malaysian Journal of Medicine and Health 
Sciences, 14(2):, 51-56 (Impact Factor : 0.107)   
  
10-Mohd Zulfakar Bin Mazlan, Nik Abdullah Bin Nik Mohamad, Mohamad Hasyizan Bin 
Hassan, Irfan Bin Mohamad, Zeti Norfidiyati Binti Salmuna@ayub, Roselinda Bt. Ab.  
Rahman, 2018, Awake fibre Optic Intubation with Dexmedetomidine for Ludwig Angina with  
Severe Trismus, Malaysian Journal of Medicine and Health Sciences, :, (Impact Factor : 0.1)   
  
  
  
  
  
  

Page 42 of 48   
  
  
  
  
CURRICULUM VITAE                                                                             
  
1. Name: DR AHMAD AKRAM OMAR   
  
2. Work Address: Department of Obstetric and Gynaecology,  
   School of Medical Sciences,  
   Health Campus,  
   Universiti Sains Malaysia.,  
   16150 Kubang Kerian,    Kelantan  
      Tel. No: 0179817277  
      E-mail Address: drakram@usm.my   
3. Academic Qualifications and Brief Career History:  
  
Year  
Degree  
Discipline  
University  
 1997-2002   
Medical Degree  
Medicine  
Universiti Sains Malaysia  
2007-2011  
Master in Medicine  
Obstetrics & 
Gynaecology  
Universiti Sains Malaysia  
2015-2016   
Clinical Fellowship  
The Asia Pacific Association for Gynaecologic 
Endoscopy and  Minimally Invasive Therapy,  
Chang Gung Memorial Hospital, Taiwan  
  
Year  
Position  
Place of Work  
 2002-2003  
House Officer  
Hospital Universiti Sains Malaysia  
2003-2004  
Medical Officer  
Hospital Raja Perempuan Zainab II  
2004-2006  
Medical officer  
Hospital Kuala Krai  
2006-2010  
Trainee lecturer O&G  
School of Medical Science, Health Campus  
Universiti Sains Malaysia  
 

Page 43 of 48   
2011-present   
Lecturer and Consultant  
Obstetric and  
Gynaecology  
Hospital Universiti Sains Malaysia  
2014  
Clinical attachment in  
Minimally Invasive  
Surgery  
Hospital Putrajaya  
  
4. Field(s) of Specialization: Obstretric and Gynaecology  
  
5. Research Area:  
Minimally Invasive Gynaecology Surgery (MIGS)  
Fertility and Reproductive Health  
  
6. Grants in the Last 5 Years: Incentive Grant USM 2019 -2020 AR Gynae Endotrainer  
 
Innovation Grant USM  
  
7. List NOT MORE than 10 Significant/Relevant/Related Journal Publications  
  
1. Hoo PS, Afendi NR, Mahamooth MIJ, Ismail AA, Rahim RA, Omar          AA. 
Review of a case of choriocarcinoma with vaginal metastases.        Edorium J 
Gynecol Obstet 2016;2:48-51.2.  
2. Hoo PS, Afendi NR, Yeng LW, Yahaya AS, Ismail AA, Rahim RA,          Omar  
AA, Ismail MP. Treat secondary amenorrhea by        oophorectomy: A case of adult 
granulosa cell tumour with pseudo-       FSH deficiency manifested by secondary 
amenorrhea. Edorium J        Gynecol Obstet 2017;3:1-4.  
3. Afendi NR, Hoo PS, Ismail AA, Rahim RA,Omar  AA, Ibrahim A.Coexistance of 
Mayer-Rokistansky-Kuster-Hauser syndrome with Turner syndrome: A case report. 
Edorium J Gynecol Obstet 2017;3,5-8.   
4. Omar  AA, Othman MS, Hoo PS, Zon EM, Ismail AA, Rahim R,        Afendi NR, 
Ibrahim A. Menstruation from the pfannensteil scar: A        case of rare presentation 
of atypical endometriosis. Edorium J        Gynecol Obstet 2017;3:1-4  
5. A.A Omar, M.S Othman, H.P Sung, E.M Zon, A.A Ismail, R. Rahim, N.R.N.M 
Afendi, A. Ibrahim, 2018, Menstruation from the pfannensteil scar: A case of rare 
presentation of atypical endometriosis, Journal of case reports and images in 
Obstetric and Gynaecology, 4/2018:, 1-4  
6. Rahimah abdul rahim, ahmad amir ismail, nik rafiza nik afendi, ahmad akram omar, 
adibah ibrahim, erinna mohamad zon, Shah Reza Johan Noor, Munirah Aminullah,  
2020, A 5-year review of seminal fluid analysis in Hospital Universiti Sains Malaysia, 
Kubang Kerian, Brunei International Medical Journal,  
7. Ahmad amir ismail, rahimah abdul rahim, ahmad akram omar, nik rafiza nik afendi, 
Hoo Pek Sung, mohd pazudin ismail, Wan   
8. Fadhlina Wan Adnan, Engku Husna Engku Ismail, Syamilah Mokhtar, 2020,  
Urinary tract infection following urodynamic study in Hospital Universiti Sains  
Malaysia, Kelantan, Brunei International Medical Journal,  
9. Ahmad Akram Bin Omar, Erinna Binti Mohamad Zon, Adibah Binti Ibrahim, 2020,  

Page 44 of 48   
Spontaneous severe ovarian hyperstimulation syndrome in a singleton pregnancy,  
BMJ Case Reports  
10. 
Ahmad Akram Bin Omar, Adibah Binti Ibrahim, 2020, Partial mole with 
coexisting fetus presented with hyperemesis gravidarum and hyperthyroidism: a case 
presentation, Taiwanese Journal of Obstetrics and Gynaecology,    
  
  
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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