Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study
Phase: PHASE4
Conditions: Deep Sedations, Conscious Sedation, Colonoscopy
Sponsor: Qassim Health Cluster

 
COVER PAGE 
 
 
OFFICIAL TITLE 
 
Evaluation of safety and efficacy of non-anesthesia provider-administered 
different anesthetic regimens during colonoscopy: a single center, prospective 
double blind, randomized study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT NUMBER:  NOT APPLICABLE  
 
Last updated Date:   6th January 2025 (01/06/2025) 
 
 
 
 
 
 

2 
Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
Author Information 
 
Principle investigator 
Dr. Mohammed Saud Alsulaimi 
Dr.abosaud@windowslive.com 
Co-author and Corresponding author 
Dr. Muhammad Yousuf Memon 
memon.dryousuf@gmail.com 
 
OTHER CO-AUTHORS 
Abdullah AlMousa 
abdu3302@gmail.com 
Ibrahim Obeidallah 
iobeidallah@yahoo.com 
Amal Noman Shamsan Mohammed 
amalnoman@yahoo.com 
Ahmed Qasem S. Ali 
ahmdqs@gmail.com 
Dr. Faris Bandar AlRashdan 
dr.faris9914@gmail.com 
Dr. Ahmed Saleh Altatar 
Sanday201511@gmail.com 
Ahmad Hamdy Zidane 
NAWADIR A. FARRAG A. RAHMAN TIYA 
Nawadirfarrag@hotmail.com 
ABDUL RASHEED ABDUL REHMAN 
abrehman999@hotmail.com 
Muhammad Adil chouhdary 
adilchouhdary7064@gmail.com 
Azizullah Shinwari 
azizshinwari86@gmail.com 
Site: King Saud Hospital, Unaizah, Qaseem, Saudi Arabia 
 
Short title: Sedation during Colonoscopy procedures 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
Contents 
1. 
Summary and Synopsis: .................................................................................. 3 
2. 
Statistical methodology .................................................................................... 4 
3. 
Introduction ...................................................................................................... 4 
4. 
Objectives ........................................................................................................ 6 
5. 
Methodology .................................................................................................... 6 
6. 
Study Design ................................................................................................... 7 
7. 
Outcome measures........................................................................................ 10 
8. 
Statistical considerations ................................................................................ 11 
9. 
Ethical considerations .................................................................................... 11 
10. 
Data handling and record keeping.................................................................. 12 
11. 
Confidentiality: ............................................................................................... 12 
12. 
Record Retention and Archiving ..................................................................... 12 
13. 
Safety reporting ............................................................................................. 12 
14. 
Finance and Funding ..................................................................................... 14 
15. 
Conflict of interests ........................................................................................ 14 
16. 
References .................................................................................................... 14 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
1. Summary and Synopsis: 
 Short title: Sedation during colonoscopy procedures 
 Methodology: Single center, prospective randomized, double blinded 
 Research sites: King Saud Hospital, Qaseem, Kingdom of Saudi Arabia 
 Objectives: To evaluate safety and efficacy of non-anesthesia provider- 
administered different anesthesia regimens for sedation during 
colonoscopy procedures 
 Number of participants: 157 
 Inclusion and exclusion criteria: 
1. Inclusion criteria: 
 Adults 18 -60 years of age 
 Both Genders 
 Indication of colonoscopy procedure without advance intervention 
 American Society of Anesthesiologist physical status I or II 
 Competent to give informed consent 
2. Exclusion criteria: 
 Personal history of allergic reaction or other contra-indications to 
midazolam, propofol or fentanyl 
 Age below 18 or above 60 years 
 Chronic use of benzodiazepines 
 American Society of Anesthesiologist physcial status III or above 
 Pregnancy 
 History of smoking or alcohol abuse 
 Body mass index > 35 kg/m2 
 History of airway obstruction or difficult intubation 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
2. Statistical methodology: 
Descriptive statistics will be used to assess the demographic and clinical 
characteristics of the 3 groups. Continuous variables will be presented by mean 
with standard deviation (SD) or median with interquartile range (IQR) as 
appropriate. Qualitative variables will be presented by numbers and percents. 
For univariate analysis, ANOVA test will be applied for continuous variables. 
Categorical data will be analysed using the chi-square or Fisher's exact tests. For 
multivariate analysis, Regression analysis will be employed for analyzing the 
relationship between variables and to adjust for potential confounding factors. In 
all tests, p value would be considered significant if less than 0.05. 
 Sample size is calculated by ANOVA F test. Fixed effects, omnibus, one-way 
Analysis: A priori: Compute required sample size Input: Effect size f = 0.25 α 
err prob = 0.05 Power (1-β err prob) = 0.80 Number of groups = 3 Output: Total 
sample size = 157 
 Study duration: December 2024 till completion of the sample size. 
 
2. Introduction: 
Colonoscopy is one of the most common procedures in the world and it is commonly 
performed outpatient method for the diagnosis and treatment of colorectal disorders (1- 
3). It is an invasive and short-lasting procedure that can cause pain, anxiety, 
restlessness and rarely vasovagal reactions. Sedation and analgesia can improve 
experience for both patients and endoscopist and are usually required for successful 
completion of the procedure (3). Globally, there are certain variations in sedative 
practices and the regimens used vary by geographic regions and even within same 
countries (4-6). 
The combination of benzodiazepines with short-acting opioids for achievement of proper 
sedation is in practice since 1980. Short-acting opioids such as fentanyl have been 
widely used in combination with midazolam for sedation during colonoscopy as both can 
be administered by endoscopists or nurses without help of anesthesia professional and 
easily reverted if required (7-10). Over the past fews years, the use of propofol - a 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
sedative, hypnotic drug- has been increased worldwide due to its rapid onset of action, 
short recovery time and lesser post operative nausea and vomiting (11, 12). However, 
the use of propofol alone may require higher doses, which leads to increased incidence 
and severity of side effects. Propofol has been evaluated in combination with 
benzodiazepines such as midazolam, and/or short- acting opioids (fentanyl), but there is 
no clear evidence as to which regimen is better and safer (13). For patients undergoing 
colonoscopy, the combination regimen of propofol-fentanyl or propofol-midazolam have 
been used in multiple centers with successful completion of procedure and patient 
satisfaction (14-16). However, adding sedatives and analgesics to propofol have their 
own risks and benefits and the selection of drugs is a critical factor in predicting the 
outcomes (17). Irrespective of the drug administered to achieve sedation, anesthesia 
during colonoscopy is linked to potential complications like hypoxia, respiratory 
depression, circulatory depression, postoperative nausea and vomiting and irregular 
heartbeats (10, 18, 19). 
Despite the rise in use of propofol alone or in combination with benzodiazepines or 
short-acting opioids, few studies have been conducted to compare and evaluate the 
effectiveness of these regimens. In certain specific conditions like IBD, colonoscopy 
with deep sedation like propofol gives good outcome in terms of endoscopist as well as 
patients satisfaction in perspective that IBD patients are mostly young and very 
sensitive. (20) We plan to conduct a prospective randomized study to compare 3 
sedative groups (1) midazolam + fentanyl (2) propofol alone (3) propofol + fentanyl in 
patients undergoing elective colonoscopy. All the colonoscopies will be performed by 
experienced endoscopist including consultants and senior specialists. The present 
study aims to compare the safety and effectiveness of different anesthesia regimens to 
achieve sedation during colonoscopy. 

7 
Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
3. Objectives: 
To evaluate safety and efficacy of non-anesthesia provider-administered different 
anesthesia regimens for sedation during colonoscopy procedures. 
4. Methodology: 
Selection criteria for study population: 
 
Adults (18 -60 years of age) with indications of colonoscopy who will present at 
the out-patient department of gastroenterology at King Saud Hospital, Unaizah, 
Saudi Arabia between December 2024 till completion of the sample size. 
Following will be the inclusion and exclusion criteria for participation in the study. 
 
1. Inclusion criteria: 
 Adults 18-60 years 
 Both Genders 
 Indication of colonoscopy procedure without advance intervention 
 American Society of Anesthesiologist physical status I or II 
 Competent to give informed consent 
 
 
2. Exclusion criteria: 
 Personal history of allergic reaction or other contra-indications to 
midazolam, propofol or fentanyl 
 Age below 18 or above 60 years 
 Chronic use of benzodiazepines 
 American Society of Anesthesiologist physcial status III or above 
 Pregnancy 
 History of smoking or alcohol abuse 
 Body mass index > 35 kg/m2 
 History of airway obstruction or difficult intubation 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
5. Study Design: 
A randomized, double-blinded prospective study will be performed at the department of 
Gastroenterology, Kind Saud Hospital, Unaizah, Qassim, Saudi Arabia, from 1st May 
2024 till the completion of the sample size. The study approval will be sought from the 
Hospital Research Ethics Committee and then ethics committee of the Ministry of 
Health –Qassim cluster. Patients fulfilling the inclusion criteria who present at the out- 
patient department of gastroenterology with an indication for elective colonosocpy will 
be included in this study. Informed consent will be taken from the participants in study 
after giving them full information about the study project including benefits and possible 
side effects of the study. 
All patients who will undergo colonoscopy with above-mentioned inclusion criteria in the 
Endoscopy unit from December 2024 till completion of the sample size will be enrolled. 
Total Sample size calculated by F test ANOVA is 157 as described above. All 
consecutive patients fulfilling the criteria will be enrolled in the study. After enrolment, 
patients will be allocated into 3 groups by simple randomization using computer-based 
Excel spreadsheet. (See flow chart). A separate nurse/doctor will be responsible for the 
preparation and administration of different sedative regimens. The study participants, 
endoscopist and principal investigator will be blinded regarding the allocation of patients 
and medication administration. To ensure patients' safety, colonoscopy procedures 
involving propofol administration by endoscopists or trained nurses will be conducted 
under the supervision of an anesthesiologist. The groups will be assigned to three 
different sedative regimens. Group I will receive intravenous midazolam + fentanyl, 
Group II participants will receive propofol only, while Group III patients will receive 
fentanyl + propofol. Dosage of each drug will be titrated according to response and 
need during the colonoscopy procedure. While there are no standard guidelines on the 
dose of propofol for sedation in endoscopy (21), a number of studies have used the 
following doses of the two drugs with very good safety profile. In a study from 
Venezuela by Ruiz-Curiel RE et al involving a total of 70,696 digestive endoscopy 
procedures, the incidence of complications was very low. Assisted ventilation with a 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
mask was required on 78 (0.11%) occasions. In this study propofol was administered by 
gastroenterologist in an induction bolus of 10 to 50 mg, continuing with intermittent 
boluses of 10 to 20 mg, according to the patients' response. (22) A study from Japan 
spanning almost 10 years with nurse-administered propofol sedation (NAPS) 
demonstrated promising results and a very good safety profile in patients undergoing 
diagnostic EGD (n = 117,661) or colonoscopy (n = 32,550) from January 2006 through 
December 2016. The only adverse event was the transient need for supplemental 
oxygen supply, required by 1950 patients (1.3%): 1689 undergoing EGD (1.4%) and 
261 undergoing colonoscopy (0.8%). The median dose of propofol administered for 
EGD was 77 mg (range, 20–160 mg) and for colonoscopy was 99 mg (range, 40–200 
mg). The maximum dose allowed was up to 200 mg (23). Lowest possible doses of 
these drugs will be administered in the present study to ensure safety. In our study 
propofol will be administered as intermittent boluses, with an induction dose of 20-50 
mg followed by intermittent boluses of 10-20 mg according to the patient's response, 
with a maximum total dose of 200 mg. (table1). It has been observed that adding 
opioids like fentanyl to propofol reduces the required dose of propofol to achieve the 
same level of sedation. Megan E. et al. in one study demonstrated the same (26) 
(Table1). 
Table1. Sedative drugs and dosages (22-27) 
 
DRUG 
DOSE 
COMMENTS 
Midazolam 
+ 
Fentanyl 
(Group I) 
Initial dose: midazolam 0.5–1 mg + 
fentanyl 12.5–75 μg 
Additional dose: midazolam 1 mg 
(2–3 min), fentanyl 12.5–50 μg (1–3 
min) 
Midazolam initially 0.015-0.03 mg/kg IV. 
May repeat with 25% of initial dose after 3- 
5 min Maximum 6 mg 
Fentanyl: .5-1 ug/kg IV over 2-3 minutes 
initially  May  repeat  after  5-10  minutes 
(maximum 100 ug) 
Propofol 
(Group II) 
induction dose of 20-50 mg followed 
by intermittent boluses of 10-20 mg 
according to the patient response 
with maximum total dose of 200 mg 
Maximum dose 200 mg 
Propofol 
+ 
Fentanyl 
(Group III) 
Initial bolus of propofol 10–20 mg, 
followed by boluses of 5–10 mg 
according to the patient response 
Fentanyl 12.5–75 μg IV over 2-3 
minutes. May repeat 12.5-50 ug 
Maximum dose 200 mg 
Maximum 100 ug 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
Allocated to group III 
(propofol AND fentanyl) 
Patients will be contacted via 
mobile phone 48 hours later to 
inquire about any adverse events 
that may have occurred and to 
assess their overall satisfaction. 
Immediately after the procedure 
(1) degree of sedation 
(2) onset of sedation 
(3) patient’s satisfaction and 
(4) procedure completion rate 
FLOW CHART 
 
 
Flow up 
Evaluation of Intervention 
Allocation 
Excluded, n= 
Failed to meet inclusion criteria, n= 
Refused to give consent, n= 
Other reasons, n= 
Enrolment 
N= 
STUDY SAMPLE 
N= 157 
Randomization (simple/block) 
Equally distributed 
Allocated to group I 
(midazolam AND fentanyl) 
Patients will be contacted via 
mobile phone 48 hours later to 
inquire about any adverse events 
that may have occurred and to 
assess their overall satisfaction. 
Immediately after the procedure 
(1) degree of sedation 
(2) onset of sedation 
(3) patient’s satisfaction and 
(4) procedure completion rate 
Allocated to group II 
(Propofol) 
Patients will be contacted via 
mobile phone 48 hours later to 
inquire about any adverse events 
that may have occurred and to 
assess their overall satisfaction. 
Immediately after the procedure 
(1) degree of sedation 
(2) onset of sedation 
(3) patient’s satisfaction and 
(4) procedure completion rate 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
All participants will be monitored by assigned nurses for vitals, oxygen saturation, ECG 
and noninvasive blood pressure before, during and post procedure. Colonoscopy will 
be performed by experienced endoscopists. All patients will be evaluated by assigned 
physican before going for colonoscopy. It will include hisory, physical examination and 
noting down for any allergy, comorbidities and ASA class. Following data elements will 
be collected: age, gender, weight and height of patients, indication of the procedure, 
total examination time, time to colonoscope into the cecum, dose of sedative drug as 
metnioned above, changes in blood pressure and oxygen saturation. Any side effects 
will be noted during or after the procedure. Adverse events were defined as follows: (1) 
hypotension was defined as a mean arterial pressure < 70 during the procedure and a 
25% drop from the presedation baseline. (2) Tachycardia was defined as a heart rate 
during the procedure >100 and a 25% increase from presedation baseline, (3) 
bradycardia was defined as a heart rate <60 during the procedure and a 25% drop from 
the presedation baseline, (4) hypoxia was defined as a desaturation to <90% during the 
procedure with a concomitant increase in supplemental oxygen. (26) 
6. Outcome measures 
The primary outcome measures would be (1) degree of sedation (2) onset of sedation 
(3) patient’s satisfaction and (4) procedure completion rate. Degree of sedation will be 
assessed by observer’s assessment of alertness/sedation (OAA/S) scale. Details are 
given in data collection sheet. The onset of sedation will be documented as “the 
duration it takes for the patient to exhibit drowsiness and reduced responsiveness 
following the administration of the sedative medication”. Secondary outcome measures 
will include adverse events, recovery time, and endoscopist’s satisfaction. Regarding 
adverse events, risk matrix sheet is attached with for each drug separately. The time to 
recover from sedation will be assessed every 10 minutes after the procedure using the 
Aldrete score. Aldrete score of 10 will be considered as full recovery and time will be 
noted from completion of the procedure till full recovery (27). Patient can be discharged 
10 minutes after achieving Aldrete score of 10. The satisfaction of both, the endoscopist 

12 
Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
and the patient, will be evaluated at the end of the procedure with 0 being dissatisfied 
and 10 being extremely satisfied.  
7. Statistical considerations: 
Descriptive statistics will be used to assess the demographic and clinical characteristics 
of the 3 groups. Continuous variables will be presented by mean with standard deviation 
(SD) or median with interquartile range (IQR) when appropriate. Qualitative variables 
will be presented by number and percent. For univariate analysis, ANOVA test will be 
applied for continuous variables. categorical data will be analysed using the chi-square 
or Fisher's exact tests. For multivariate analysis, Regression analysis will be employed 
for analyzing the relationship between variables and to adjust for potential confounding 
factors. In all tests, P-value of less than 0.05 will be considered statistically significant. 
SPSS version 23 will be used for the analysis of data. 
Interim Analysis 
 
Interim analysis will be done by safety and monitoring board intermittently at completion 
of 25%, 50% and 75% of the study. Study will be stopped if significant difference is 
observed in different groups. 
8. Ethical considerations: 
The study will be conducted in accordance with the Declaration of Helsinki and the 
guidelines of the International Conference on Harmonisation. After approval from 
Hospital ethical committee, the study protocol will be submitted for approval to the 
ministry of Health-Qassim local ethics committee. All the data will be de-identified and 
only after de-identification, data will be analysed to ensure data safety and 
confidentiality. The data will only be accessible to approved personnel involved in the 
study.This data will be kept secure and protected by password. Nor the identity neither 
the personal information will be revealed in the research publication. 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
9. Data handling and record keeping: 
Data Collection will be done by manual recording and subsequently transcribed to an 
electronic excel sheet. A separate doctor will be assigned to fill the data sheet of the 
participants with all details mentioned in the data collection sheet. All the manual 
recorded sheets will be kept in a locked and secure place. And its electronic form will be 
recorded and protected with secure password protected files. 
10. Confidentiality: 
The Principal Investigator and designees, employees and agents involved with this 
study will comply with relevant state and federal laws relating to the confidentiality, 
privacy and security of a participants’ health information. 
11. Record Retention and Archiving: 
Original source documents, study records, and reports will be maintained by the 
investigator for a period of ten years after the investigation is terminated or completed. 
This record will not be shared and will be kept safe and protected. 
12. Safety reporting 
Any adverse events that occur during the study that the investigator believes are 
serious and qualify as either an unanticipated adverse device effect OR are related to 
study-specific procedures as defined must be immediately (but at least within 24 hours) 
reported to local hospital administration and healthcare body. The local Institutional 
Review Board will also be informed in a timely manner. The investigator will then submit 
a detailed written report to the Institutional Review Board no later than 5 days after the 
investigator discovers the event. PI will be responsible for reporting any reportable 
serious, unexpected, study-related adverse events from this study to the applicable 
regulatory agencies. 
 Adverse Events (AEs): An AE is any untoward medical occurrence in a 
participant to whom an intervention has been administered, including 
occurrences which are not necessarily caused by or related to that 
intervention. 

14 
Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
An AE can therefore be any unfavourable or unintended sign (including an 
abnormal laboratory finding), symptom or disease temporally associated with 
study activities. 
 Adverse Reaction (ARs): An AR is any untoward and unintended response in a 
participant to an intervention. All adverse events judged by either the reporting 
investigator or the sponsor as having a reasonable causal relationship to the 
intervention qualify as adverse reactions. 
 Notification and reporting of Adverse Events and Reactions: If the AE is not 
defined as serious, the AE will be recorded in the study documents and the 
participant followed up by the research team. The AE will be documented in 
the participants’ source documents, the Case Report Form (CRF), and, where 
appropriate, medical records. 
 Serious Adverse Events (SAEs) or reactions: A serious adverse event (SAE) is 
defined as an untoward occurrence that: 
 Results in death, 
 Is life-threatening, 
 Requires hospitalisation or prolongation of existing hospitalisation, 
 Results in persistent or significant disability or incapacity, 
 Consists of a congenital anomaly or birth defect, or 
 Is otherwise considered medically significant by the investigator. 
 
 
 SARs will be reported to the REC where in the opinion of the Chief Investigator 
the event was serious and: Related (it may have resulted from administration 
of any of the research interventions), and Unexpected (the type of event is not 
listed in the protocol or other Reference Safety Information as an expected 
occurrence). 
 
 Notification and reporting of Serious Adverse Events Serious Adverse Events 
(SAEs) that are considered to be ‘related’ and ‘unexpected’ will be reported to the 
sponsor or PI within 24 hours of learning of the event, and to the REC within 15 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
days in line with the required timeframe. The treatment code for the participant will be 
broken when reporting an ‘unexpected and related’ SAE. The un-blinding of individual 
participants by the PI in the course of a clinical study will only be performed if necessary 
for the safety of the study participant. 
 
 Urgent Safety Measures: The PI will take urgent safety measures if necessary to 
ensure the safety and protection of the clinical study participant from 
immediate hazards to their health and safety. The measures will be taken 
immediately. The approval of the REC prior to implementing urgent safety 
measures is not required. However, the PI will inform the sponsor and 
Research Ethics Committee (via telephone) of this event immediately. The PI 
will inform the REC in writing within 3 days, in the form of a substantial 
amendment. 
 
Overview of the Safety Reporting responsibilities: The PI is the medical assessor on 
behalf of the sponsor and will review all events reported. The PI will ensure that safety 
monitoring and reporting is conducted in accordance with the sponsor’s requirements. 
 
 
13. Finance and Funding: 
 None declared. 
 
14. Conflict of interests: 
 None declared. 
 
 
 
 
 
 
 

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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
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Evaluation of safety and efficacy of non-anesthesia provider-administered different anesthetic regimens during colonoscopy: a single center, 
prospective double blind, randomized study 
  
 
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