Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements: A Randomised Double-Blinded Controlled Study
Phase: NA
Conditions: Cholelithiases, Appendicitis, Ovarian Cysts
Sponsor: Universiti Kebangsaan Malaysia Medical Centre

 
 
 
 
 
 
 
 
 
 
 
EFFECT OF INTRAVENOUS LIGNOCAINE INFUSION ON INTRAOPERATIVE 
END TIDAL DESFLURANE CONCENTRATION REQUIREMENTS: A 
RANDOMISED DOUBLE-BLINDED CONTROLLED STUDY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Document Date: 25/05/2021 
 

 
 
INTRODUCTION 
 
Lignocaine is an amide local anaesthetic and class 1B antiarrhythmic that is widely 
used in all medical and surgical fields. It also contains analgesic, antinociceptive, immune-
modulating and anti-inflammatory actions.1 There are many clinical studies demonstrating 
lignocaine’s many perioperative benefits. Yang et al (2020) in a systemic and meta-analysis 
review showed that giving IV lignocaine in the perioperative period was safe, reduced airway 
complications, obtunds cough reflex and reduce sore throat.2 Other reported advantages of 
systemic lignocaine administration include pain reduction, reduced opioid consumption, 
nausea, ileus duration and length of hospital stay.3-6 These benefits has been shown to persist 
from the onset of its effects up to 36 hours after infusion has been terminated.5, 7  
In addition to its analgesic properties, systemic lignocaine has a minimum alveolar 
concentration (MAC) sparring effect on volatile anaesthetics which has been proved in multiple 
animal studies.8-11 The mechanism for lignocaine’s MAC sparring effect is likely due to 
blockage of sodium channels.8 Recently, Omar et al (2019) and Weinberg et al (2017) 
demonstrated in their clinical studies that parenteral lignocaine reduced Bispectral index (BIS) 
guided sevoflurane requirements.12, 13 Weinberg et al (2017) also tabulated data from numerous 
trials which detailed the effects of parenteral lignocaine in reducing volatile agent 
requirements.13 Cardiovascular depression and risk of post-operative nausea and vomiting are 
related to volatile agents in a dose dependent manner.14, 15 Lower volatile agents requirement 
should result in a more favourable cardiovascular profile which would be beneficial in 
hypovolemic patients and those with low cardiac reserves. Furthermore, coupled with opioid 
reduction, incidence of post-operative nausea and vomiting could be reduced. Awakening from 
volatile agent anaesthesia is dependent on its washout from alveolar ventilation and its dose at 
end of surgery.16 Therefore, it is postulated that emergence and extubation time might be faster 
resulting in more efficient utilisation of the operation theatre. 
Clinical effects of IV lignocaine infusion are widely reported to be seen at 1-2 mg kg-1 
h-1 which results in plasma levels below 5 mcg ml-1.3-5, 7, 17 Context sensitive halftime after a 
3-day infusion is about 20-40 min and there is no accumulation in healthy individuals.5 
However, its clinical effectiveness differs between types of surgery, possibly due to sample 
size and design of the studies.3 Patient safety is of paramount importance hence it should be 
noted that measurement of plasma levels of lignocaine is not widely available in Malaysia and 

there is limited data regarding its optimal dosing and duration. Lignocaine has a narrow 
therapeutic index whereby CNS toxicity (numbness of tongue, metallic taste, light headedness 
and tinnitus) will begin to manifest when plasma concentration exceeds 5 mcg ml-1 and if left 
untreated, will progress to visual disturbances, muscle twitching, unconsciousness, seizure, 
respiratory arrest and cardiovascular collapse.5 Cardiovascular toxicity is a rare and late 
complication as it usually occurs at plasma levels exceeding 10 mcg ml-1 which is well above 
that is required for neurological toxicity.5 In the event of severe toxicity, intralipid can be given 
as per the guideline provided by the Association of Anaesthetists for Great Britain and Ireland. 
 
Desflurane is an inhalational anaesthetic agent with a low blood: gas coefficient (0.42) 
which allows for more precise control of the level of anaesthesia, rapid induction and rapid 
emergence resulting in shorter recovery when compared to other inhalational agents like 
sevoflurane.18, 14, 19 Therefore, it is preferably used for long surgery, bariatric surgery, obese 
patients or elderly patients as the faster offset leads to early wake up which minimises the risk 
of respiratory depression that is commonly associated with these cases.14, 18, 19 These 
characteristics also makes it suitable for ambulatory and day-care surgery.14 As little as 0.02% 
are metabolised in vivo, hence no dose adjustment is needed for patients with renal or hepatic 
dysfunction while the rest are vented to the environment without much or any degradation.14, 
18, 19 However, due to its high cost, it is not widely used for all cases. 
To the best of our knowledge, there is no research on the effects of IV lignocaine 
infusion on intraoperative desflurane requirements in human population. Reduction of 
desflurane requirements when coupled with the reported benefits of IV lignocaine, will 
contribute to a high quality, cost effective, optimal, balanced and safe provision of anaesthesia. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
OBJECTIVE 
 
1. To investigate the effect of IV lignocaine on the end tidal desflurane concentration 
required to maintain BIS values between 40-60. 
2. To compare intraoperative haemodynamic changes in patient with intravenous 
lignocaine vs normal saline. 
 
MATERIALS AND METHODS 
 
This prospective, double-blinded, randomised controlled study will be submitted for 
the approval of the Research Committee of Department of Anaesthesiology & Intensive Care, 
Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Research & Ethics Committee, 
UKMMC and will be registered at ClinicalTrials.gov. 
Written informed consent will be obtained from selected patients recruited into the 
study, which will be conducted by a single operator who is the principal investigator of this 
study. The study will be conducted in Hospital Universiti Kebangsaan Malaysia, Kuala 
Lumpur. 
 
Inclusion Criteria: 
1. American Society of Anaesthesiology (ASA) I or II patients. 
2. Patients aged between 18-75 years of age. 
3. Patients scheduled for elective laparoscopic cholecystectomy. 
4. Patients scheduled for laparoscopic hernioplasty. 
5. Patients scheduled for emergency laparoscopic appendicectomy. 
6. Patients scheduled for emergency laparoscopic cystectomy. 
7. Patient weight ranging from 50 – 100 kg. 
8. Surgery lasting at least one hour. 
 
Exclusion Criteria: 
1. Patients with a known allergy to study drug. 
2. Patients with body mass index (BMI) more than 35 kg m-2. 
3. Patients who are taking sedatives. 

4. Patients with chronic substance abuse. 
5. Patients with history of seizures, psychiatric disorders, cardiac failure, arrythmias, 
hepatic or renal dysfunction. 
6. Patients who are taking class IB antiarrhythmics or amiodarone. 
7. Surgery lasting more than 3 hours. 
 
Methodology: 
 
 
Patient will be reviewed and recruited during premedication round, written consent will 
be explained and obtained. Patients will be fasted for at least six hours before their surgery. 
Tablet paracetamol 1g will be given to patients once they are called to operation theatre. 
 
Patients will be randomly assigned into two groups based on computer generated 
randomisation tables. Group A will receive intraoperative lignocaine while Group B will 
receive normal saline. The study drugs will be prepared by an anaesthetist registrar who is not 
involved in the study. Each drug syringe will be coded and given to the primary investigator 
who will be blinded. 
 
In the operation theatre, intravenous access will be obtained using an 18 G cannula in 
all patients and infusion of crystalloid will be started. Standard monitoring will then be applied 
using continuous electrocardiography (ECG), non-invasive blood pressure (NIBP) monitoring, 
pulse oximetry and capnography. BIS (BIS Quatro™, USA) will be used to assess the depth of 
anaesthesia for all patients and baseline values for BIS shall be obtained prior to induction. Pre 
induction blood pressure (BP) and heart rate (HR) will also be recorded. The study drugs will 
be given 5 min before induction of anaesthesia and two syringe pumps will be used to deliver 
the study drugs. First, a bolus of the study drug prepared in a 10 ml syringe will be given to the 
patient over a period of 3 min via the syringe pump. The time of initiation of the bolus will be 
taken. After bolus, the BP and HR will be recorded. Subsequently, infusion of the study drug 
prepared in a 20 ml syringe will be started and continued until the end of surgery using the 
other syringe pump. The time at the start of infusion will be taken. 
 
Group A will receive an IV bolus dose of 1.5 mg kg-1 of 2% lignocaine HCL diluted up 
to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over 
a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg kg-1 h-1 of 2% 

lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump. 
Patients in Group B will receive an IV bolus of 10 ml of normal saline over a period of 3 min 
followed by an IV infusion of an equal volume of normal saline, both of which will be delivered 
by separate syringe pumps.  
 
Anaesthesia will be induced with IV fentanyl 2 mcg kg-1 followed by IV propofol 2-3 
mg kg-1 and IV rocuronium 0.6 mg kg-1. After 3 minutes of mask ventilation with only 100% 
oxygen, tracheal intubation using an appropriately sized endotracheal tube (ETT) will be 
performed to secure patient’s airway. The patient will then be connected to Aisys CS2 
anaesthesia machine and the lungs will be ventilated with desflurane in 50% oxygen-air balance 
at a tidal volume of 6-8 ml kg-1. End tidal CO2 (EtCO2) level will be maintained between 35-
45 by adjusting the respiratory rate. The time of induction and intubation will be documented. 
 
Anaesthesia shall be maintained with desflurane, in 50% oxygen-air balance with a total 
flow of 1.0 L min-1. The end tidal desflurane (Et-Des) concentration will be adjusted to 
maintain a target BIS of between 40-60. BIS, MAC values, Et-Des concentration, BP and HR 
will be recorded every 10 min from the time of induction until the end of surgery. IV parecoxib 
40 mg will be given to all patients. Boluses of IV fentanyl 50 mcg will also be given to maintain 
blood pressures within 20% of pre-operative levels. Dosage of fentanyl given post induction 
will be recorded. Bolus of IV ephedrine 6 mg will be given during hypotensive episodes with 
HR less than 60 beat per min while those with normal HR will be given a bolus of IV 
phenylephrine 100 mcg. Patients will also be given IV dexamethasone 8 mg post induction and 
IV granisetron 1 mg 30 mins before end of surgery to reduce the risk of post-operative nausea 
and vomiting. Core temperatures will be maintained above 35 °C with fluid warmer and 
warming blanket. If surgery lasts more than 3 hours, patient will be excluded from the study 
and infusion of the study drug will be stopped. 
 
Desflurane and study infusions will be discontinued and estimation of desflurane cost 
will be estimated at the end of surgery. Neuromuscular block will be reversed with a 
combination of IV atropine 1 mg and IV neostigmine 2.5 mg. When the patient meets all criteria 
for extubation, the ETT will be removed. Time to extubation (defined as time from desflurane 
discontinuation to tracheal extubation) will be recorded. Pain score will be assessed in recovery 
bay and if required, patient will be given patient-controlled analgesia morphine. 
 

Signs of lignocaine toxicity will be monitored in all patients beginning from the time 
of bolus of the study drug until one-hour post operatively in the recovery bay. During general 
anaesthesia, signs of lignocaine toxicity that will be looked out for include an initial tachycardia 
and hypertension followed by prolonged PR interval, widened QRS, sinus bradycardia, 
ventricular arrhythmias, hypotension and cardiac arrest. When the patient is awake in recovery 
bay, along with late signs of lignocaine toxicity as mentioned above, patient will be observed 
for one hour for early signs and symptoms characterised by perioral numbness, tinnitus, light 
headedness, visual disturbances, muscle twitching, seizure, altered mental state and respiratory 
arrest. If any of these were to occur, then infusion of the study drug will be stopped and these 
patients will be excluded from the study and managed according to hospital protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STATISCAL ANALYSIS 
 
a) Sample size calculation: 
The α value is set at 0.01 and power of study at 90%. The sample size is calculated 
using t- test. Calculation as derived from a study by Kuo et al (2006) and Omar et al 
(2019).6, 12 
 
The sample size is calculated using the “Power and Sample Size Calculations” program. 
Sample size was calculated using t-test. 
Requested output: Sample size 
Design: Independent 
Input: α = 0.01; power = 0.9; δ = 0.5; σ = 0.4; M = 1 
Case sample size: 21 x 2 plus 10% drop out rate = 48 
Sample = 24 per study group 
 
b) Statistical test: 
Analysis will be analysed using SPSS software for windows. The Kolmogorov-
Smirnov test will be used to assess variable normality distribution. Categorical 
variables will be analysed by chi square test. Continuous variables will be compared 
using student’s t -test. p value less than 0.05 will be regarded as statistically significant. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FLOW CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients for scheduled for laparoscopic cholecystectomy/appendicectomy/cystectomy/hernioplasty 
• ASA I or II patients 
• Age 18-60 years old 
• Weight 50 – 100 kg 
• Surgery lasting more 
than one hour 
• Patients with a known allergy to study drug 
• Patients with BMI > 35 kg m-2 
• Patients who are taking sedatives 
• Patients with chronic substance abuse 
• Patients with history of seizures, psychiatric disorders, cardiac 
failure, arrythmias, hepatic or renal dysfunction 
• Patients who are taking class IB antiarrhythmics or amiodarone. 
• Surgery lasting more than 3 hours 
Written informed consent 
explained and obtained 
Excluded 
Random allocation into Group A (lignocaine) or Group B (normal saline) 
Group A 
IV bolus of 1.5 mg kg-1 of lignocaine 2% diluted 
in 10 ml syringe over 3 mins followed by infusion 
at 1 mg kg-1 h-1 of lignocaine 2% in 20 ml syringe 
Group B 
Bolus followed by infusion of equal value of 
normal saline 
 
In OT 
• Monitor: ECG, NIBP, HR, Pulse oximetry, capnography, temperature probe, BIS 
• Record Baseline BIS values, pre induction BP/HR 
• Study drug given 5 min prior to induction 
• Induction of anaesthesia with fentanyl 2 mcg kg-1 and propofol 2-3 mg kg-1 
• Intubation with appropriate size ETT to secure airway 
• Tidal volume 6-8 ml kg-1, maintain Et-CO2 between 35-45 
• Anaesthesia maintained with desflurane in 50% oxygen-air balance 
• Adjust Et-Des to maintain BIS values at 40-60 
• Stop study drug and desflurane at end of surgery 
• Extubate patient when all criteria met 
• Et-Des, MAC, BIS, BP and HR values are 
recorded at 10 mins interval from time of 
induction 
• Record time of bolus and infusion of study drug 
• Record total amount of IV fentanyl given 
• Document time to extubation 
• Estimation of desflurane cost at end of surgery 
• Multimodal analgesia with IV PCM 1g and IV 
parecoxib 40 mg 
• IV dexamethasone 8 mg post induction 
• IV granisetron 1 mg 30 min before end of 
surgery 
• IV ephedrine 6 mg for IV phenylephrine 100 
mcg for hypotensive episodes 
• Monitor for lignocaine toxicity all throughout surgery from time of bolus of study drug 
• Look for CVS signs when patient intubated: initial tachycardia and hypertension followed by prolonged PR 
interval, widened QRS, sinus bradycardia, ventricular arrhythmias and cardiac arrest 
• Stop infusion of study drugs in case of toxicity 
• Monitor for 1 hour in recovery and observe for early signs and symptoms of lignocaine toxicity 

 
 
 

 
 
 

GANTT CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
March 
2020 
April - 
October
2020 
Dec 
2020-
May 
2021 
June 
2021 
July 
2021 
August 
2021 
Sept 
2021 
October 
2021 
Proposal 
Presentation to 
Research 
Committee, Dept of 
Anaesthesiology, 
UKMMC 
 
 
 
**** 
 
 
 
 
 
 
 
Proposal submission 
to Research & 
Ethics Committee, 
UKMMC 
 
 
 
**** 
 
 
 
 
 
 
Data collection 
 
 
**** 
 
 
 
 
 
Data analysis 
 
 
 
**** 
 
 
 
 
Project write- up 
 
 
 
 
**** 
 
 
 
Presentation on 
preliminary report 
 
 
 
 
 
**** 
 
 
 
Presentation on final 
report 
 
 
 
 
 
 
**** 
 
Submission to SPS 
 
 
 
 
 
 
 
**** 

DATA COLLECTION SHEET 
 
Study Number:_______________________ 
 
1. DEMOGRAPHIC DATA 
Age 
 
 
Gender 
 
Male/ Female 
ASA 
 
I/ II 
Weight (kg) 
 
 
Height (m) 
 
 
Past medical illness 
(if any state current 
medications) 
 
 
 
 
 
 
Diagnosis 
 
Surgical Procedure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2. INTRAOPERATIVE DATA 
 
Pre-indcution  
 
: BP___/___mm Hg ; HR___bpm 
 
 
   
Baseline BIS  
 
:______ 
Time of study drug bolus 
:______ 
Time of study drug infusion :______ 
Post bolus  
 
 
: BP___/___mm Hg ; HR___bpm 
Time of induction  
 
:______ 
Time of intubation 
 
:______ 
 
Time (min) 
0* 
10 
20 
30 
40 
50 
60 
70 
80 
90 
BP (mm Hg) 
 
 
 
 
 
 
 
 
 
 
HR (bpm) 
 
 
 
 
 
 
 
 
 
 
Et-Des 
 
 
 
 
 
 
 
 
 
 
MAC 
 
 
 
 
 
 
 
 
 
 
BIS 
 
 
 
 
 
 
 
 
 
 
 
Time (min) 
100 
110 
120 
130 
140 
150 
160 
170 
180 
190 
BP (mm Hg) 
 
 
 
 
 
 
 
 
 
 
HR (bpm) 
 
 
 
 
 
 
 
 
 
 
Et-Des 
 
 
 
 
 
 
 
 
 
 
MAC 
 
 
 
 
 
 
 
 
 
 
BIS 
 
 
 
 
 
 
 
 
 
 
*Pre induction 
IV Paracetamol 1g 
 
 
 
: 
IV Paracoxib 40 mg  
 
 
: 
Total bolus of fentanyl given (mcg)  
:________ 
Time to extubation (min) 
 
 
:________ 
Amount of agent used (ml) 
 
 
:________ 
Agent cost (RM) 
 
 
 
:________ 

 
3. Lignocaine side effects/toxicity 
 
Signs and symptoms of toxicity 
 
Intraoperatively after bolus of study medication 
CVS signs: 
• Initial hypertension and tachycardia 
• Sinus bradycardia 
• Conduction blocks (prolonged PR/QRS complex) 
• Ventricula arryhtmias (VT, VF, Torsade de Pointes) 
• Hypotension 
• Asystole 
 
 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
In recovery (observe for 1 hour) 
Neurological symptoms: 
• Circumoral and/or tongue numbness 
• Metallic taste 
• Drowsiness/ light-headedness 
• Tinnitus 
• Blurring of vision 
• Agitation/ confusion 
• Loss of consciousness 
• Tonic-clonic convulsion 
CVS signs: 
• Initial hypertension and tachycardia 
• Sinus bradycardia 
• Conduction blocks (prolonged PR/QRS complex) 
• Ventricula arryhtmias (VT, VF, Torsade de Pointes) 
• Hypotension 
• Asystole 
 
 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
• YES/NO 
 
 
 
 

 
BUDGET PROPOSAL 
 
No. 
Item 
Price Per Unit (RM) 
Quantity 
Total (RM) 
2. 
BIS strip 
125 
46 
5750 
3.  
IV Paracetamol 
10 
46 
460 
4. 
IV Parecoxib 
30 
46 
1380 
5. 
Desflurane 
500 
8 
4000 
Total 
11590 
 
 
 
REFERENCES 
1. 
Weinberg, Laurence. 2015. Pharmacokinetics and pharmacodynamics of lignocaine: 
A review.  World Journal of Anesthesiology 4 (2). doi: 10.5313/wja.v4.i2.17. 
2. 
Yang, S. S., N. N. Wang, T. Postonogova, G. J. Yang, M. McGillion, F. Beique, and 
T. Schricker. 2020. Intravenous lidocaine to prevent postoperative airway 
complications in adults: a systematic review and meta-analysis.  Br J Anaesth. doi: 
10.1016/j.bja.2019.11.033. 
3. 
Dunn, Lauren K., and Marcel E. Durieux. 2017. Perioperative Use of Intravenous 
Lidocaine.  Anesthesiology: The Journal of the American Society of Anesthesiologists 
126 (4):729-737. doi: 10.1097/ALN.0000000000001527. 
4. 
Kaba, A., S. R. Laurent, B. J. Detroz, D. I. Sessler, M. E. Durieux, M. L. Lamy, and J. 
L. Joris. 2007. Intravenous lidocaine infusion facilitates acute rehabilitation after 
laparoscopic colectomy.  Anesthesiology 106 (1):11-8; discussion 5-6. doi: 
10.1097/00000542-200701000-00007. 
5. 
Eipe, N, S Gupta, and J Penning. 2016. Intravenous lidocaine for acute pain: an 
evidence-based clinical update.  BJA Education 16 (9):292-298. doi: 
10.1093/bjaed/mkw008. 
6. 
Kuo, C. P., S. W. Jao, K. M. Chen, C. S. Wong, C. C. Yeh, M. J. Sheen, and C. T. 
Wu. 2006. Comparison of the effects of thoracic epidural analgesia and i.v. infusion 
with lidocaine on cytokine response, postoperative pain and bowel function in patients 
undergoing colonic surgery.  Br J Anaesth 97 (5):640-6. doi: 10.1093/bja/ael217. 
7. 
Koppert, W., M. Weigand, F. Neumann, R. Sittl, J. Schuettler, M. Schmelz, and W. 
Hering. 2004. Perioperative intravenous lidocaine has preventive effects on 
postoperative pain and morphine consumption after major abdominal surgery.  Anesth 
Analg 98 (4):1050-5, table of contents. doi: 10.1213/01.ane.0000104582.71710.ee. 
8. 
Reed, R., and T. Doherty. 2018. Minimum alveolar concentration: Key concepts and a 
review of its pharmacological reduction in dogs. Part 2.  Res Vet Sci 118:27-33. doi: 
10.1016/j.rvsc.2018.01.009. 
9. 
Acevedo-Arcique, Carlos M., José A. Ibancovichi, Julio R. Chavez, Eduardo 
Gutierrez-Blanco, Rafael Moran-Muñoz, José M. Victoria-Mora, Francisco Tendillo-
Cortijo, Martín Santos-González, and Pedro Sanchez-Aparicio. 2014. Lidocaine, 
dexmedetomidine and their combination reduce isoflurane minimum alveolar 
concentration in dogs.  PloS one 9 (9):e106620-e106620. doi: 
10.1371/journal.pone.0106620. 
10. 
Rezende, M. L., A. E. Wagner, K. R. Mama, T. H. Ferreira, and E. P. Steffey. 2011. 
Effects of intravenous administration of lidocaine on the minimum alveolar 

concentration of sevoflurane in horses.  Am J Vet Res 72 (4):446-51. doi: 
10.2460/ajvr.72.4.446. 
11. 
Pypendop, B. H., and J. E. Ilkiw. 2005. The effects of intravenous lidocaine 
administration on the minimum alveolar concentration of isoflurane in cats.  Anesth 
Analg 100 (1):97-101. doi: 10.1213/01.ANE.0000139350.88158.38. 
12. 
Omar, Ahmed M., and Ossama H. Aboushanab. 2019. Effect of intravenous lidocaine 
infusion on sevoflurane requirements as monitored by bispectral index: A randomized 
double-blinded controlled study.  Egyptian Journal of Anaesthesia 29 (3):235-239. 
doi: 10.1016/j.egja.2013.01.006. 
13. 
Weinberg, Laurence, Jae Jang, Clive Rachbuch, Chong Tan, Raymond Hu, and Larry 
McNicol. 2017. The effects of intravenous lignocaine on depth of anaesthesia and 
intraoperative haemodynamics during open radical prostatectomy.  BMC research 
notes 10 (1):248-248. doi: 10.1186/s13104-017-2570-4. 
14. 
Kapoor, Mukul Chandra, and Mahesh Vakamudi. 2012. Desflurane - revisited.  
Journal of anaesthesiology, clinical pharmacology 28 (1):92-100. doi: 10.4103/0970-
9185.92455. 
15. 
Pierre, Sébastien, and Rachel Whelan. 2012. Nausea and vomiting after surgery.  
Continuing Education in Anaesthesia Critical Care & Pain 13 (1):28-32. doi: 
10.1093/bjaceaccp/mks046. 
16. 
Sinclair, Rhona C F, and Richard J Faleiro. 2006. Delayed recovery of consciousness 
after anaesthesia.  Continuing Education in Anaesthesia Critical Care & Pain 6 
(3):114-118. doi: 10.1093/bjaceaccp/mkl020. 
17. 
Groudine, S. B., H. A. Fisher, R. P. Kaufman, Jr., M. K. Patel, L. J. Wilkins, S. A. 
Mehta, and P. D. Lumb. 1998. Intravenous lidocaine speeds the return of bowel 
function, decreases postoperative pain, and shortens hospital stay in patients 
undergoing radical retropubic prostatectomy.  Anesth Analg 86 (2):235-9. doi: 
10.1097/00000539-199802000-00003. 
18. 
Calvey., T.N, and N.E Williams. 2008. Inhalational Anaesthetic Agents. In Principles 
and Practice of Pharmacology for Anaesthetists, 129-148. Blackwell Publishing. 
19. 
Peck, T. E., and S. A. Hill. 2014. General anaesthetic agents. In Pharmacology for 
Anaesthesia and Intensive Care, 93-125. Cambridge: Cambridge University Press. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
PATIENT INFORMATION SHEET 
AND 
CONSENT FORM 
(FOR ADULT PATIENTS) 
 
 
 
 
 
 
 
 
 
 

INFORMATION SHEET FOR PATIENT 
Research Title 
Effect of intravenous lignocaine infusion on intraoperative desflurane requirements. 
 
Introduction 
Lignocaine is a widely used medication which is used to prevent pain to a specific area of the 
body for surgery. It is also used to control severe and fast abnormal heart rate, reducing pain, 
nausea, cough and sore throat after surgery. Desflurane is a gas that is commonly used for 
general anaesthesia whereby a patient is rendered unconscious, thus unaware of events and 
does not feel pain. It can be used safely for all patients but more suitable for obese patients with 
breathing problems and long surgery as awakening from general anaesthesia is quicker with 
less drowsiness. Bispectral index (BIS) is a strip of sensor placed on patient’s forehead to assess 
the patient’s level of unconsciousness during general anaesthesia and to guide dosing of 
desflurane. The aim of this study is to investigate the effect of lignocaine in reducing desflurane 
requirement as guided by BIS during the surgery under general anaesthesia. 
 
What would this involve? 
Patients who participate in this study will receive one of two injections (lignocaine or normal 
saline) through the vein. The injections will be given before general anaesthesia and continued 
through infusion until the operation ends. The concentration of desflurane used as guided by 
BIS will be recorded. 
 
The Benefits 
The researched performed will help to reduce the requirement of desflurane which will in turn 
reduce its cost and side effects. Together with the added benefits of lignocaine, this will lead 
to a safer and better provision of anaesthesia in the future. 
 
The risks 
Uncommon mild side effects of lignocaine include light-headedness, anxiety, numbness in the 
mouth, blurring of vision, metallic taste, ringing in the ears and nausea or vomiting. Severe and 
rare complications include fits, trouble breathing, unconsciousness, abnormal heart rate, 
complete stoppage of heart and severe allergy to lignocaine. However, these are unlikely to 
occur in our study because only a small dose of lignocaine is used. Your vital signs will be 
constantly monitored throughout the operation and post operatively and should any side effects 
developed; the study medications will be stopped immediately. In the event of severe side 
effects, an antidote and appropriate rescue medications will be administered immediately and 
you will be transferred to ICU for advanced care. 
 
Desflurane can cause nausea and vomiting which can be minimised with medication given 
during and after operation. Other side effects include increased salivation, coughing, airway 
blockade, low blood pressure and increased heart rate which depends on the dose delivered and 
usually reversible. Hence, should such side effects occur, it will be adjusted to its appropriate 
dose and suitable medications may be given to counter such side effects. 
 
Confidentiality 
The result of data obtained will be reported in a collective manner with no reference to a 
specific individual. Hence data from each individual will remain confidential. 
 
 

Do I have to take part? 
The participation into this study is voluntary. If you prefer not to take part, you do not have to 
give reason and your decision will not affect the treatment given. 
 
The right to withdraw 
Patient has the right to withdraw from study at any time without affecting future treatment. 
 
Payment and compensation 
You do not have to pay for participating in this study. Similarly, no payment is available to you 
for participating in this study. 
 
If I have any questions, whom can I ask at any point of this study? 
Dr Wilson Matthew Rona 
 
 
 
Dr. Syarifah Noor Nazihah Sayed Masri 
Department of Anaesthesiology 
 
 
Department of Anaesthesiology 
PPUKM 
 
 
 
 
 
PPUKM 
Mobile No: 016-8607824 
 
 
 
Mobile No: 013-3452456 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

INFORMED CONSENT FORM 
 
Research Title: …………………………………………………… 
Researcher’s Name: ……………………………………………… 
 
I, ………………………………………, IC No:  …………………......... 
• have read the information in the Patient Information Sheet including information 
regarding the risk in this study. 
• have been given time to think about it and all of my questions have been answered to 
my satisfaction. 
• understand that I may freely choose to withdraw from this study at anytime without 
reason and without repercussion. 
• understand that my anonymity will be ensured in the write-up. 
 
I voluntarily agree 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. 
 
 
 
……………………………….                           
 
 
 
………………….. 
(Signature) 
 
 
 
 
 
 
 
         (Date) 
 
 
 
 
 
………………………………. 
Witness (if any) 
 
 
………………………………. 
(Signature)           
 
 
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(IC Number) 
 
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(Date)                               
 
 
 
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Researcher 
 
 
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(Signature)           
 
 
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(IC Number) 
 
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(Date)