Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures: A Prospective, Randomized, Comparative Study
Phase: PHASE4
Conditions: Upper Gastrointestinal Endoscopy, Anesthesia
Sponsor: Ain Shams University

 
 
Official Title: 
 
 Efficacy of Propofol Combination with either Ketamine, 
Dexmedetomidine or Midazolam for Sedation during Upper 
Gastrointestinal Endoscopic Procedures: A Prospective, 
Randomized, Comparative Study 
 
 NCT Number: 
Pending (to be assigned by ClinicalTrials.gov) 
 
Document Type: 
Study Protocol 
 
Version/Date: 
Version 1.0 – July 20, 2024 
 

 
MasterDegreeThesis/MFA/ISRO/FacultyOfMedicine/ASU 
 
 
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PROTOCOL OF A THESIS FOR PARTIAL FULFILMENT OF 
M.D. DEGREE IN ANESTHESIA 
 
Efficacy of Propofol Combination with either Ketamine, 
Dexmedetomidine or Midazolam for Sedation during Upper 
Gastrointestinal Endoscopic Procedures: A Prospective, 
Randomized, Comparative Study 
 
Postgraduate Student:  
Hazem Mohamed Sabry Abdelaziz 
Degree:  
M.B.B.CH., M.Sc, Ain-Shams University 
 
 
DIRECTOR: 
Prof. Dr. Gihan Seif El-Nasr Mohamed 
Academic Position: 
Professor of Anesthesia, Intensive Care and Pain Management        
Faculty of Medicine, Ain-Shams University 
 
 
CO-DIRECTOR: 
Prof. Dr. Eman Mohamed Kamal Abu Seif 
Academic Position: 
Professor of Anesthesia, Intensive Care and Pain Management 
Faculty of Medicine, Ain-Shams University 
 
 
CO-DIRECTOR: 
Dr. Amr Fouad Hafez Helmy 
Academic Position: 
Assistant Professor of Anesthesia, Intensive Care and Pain 
Management 
Faculty of Medicine, Ain-Shams University 
 
 
CO-DIRECTOR: 
Dr. Ahmed Moustafa Mohamed Mohamed 
Academic Position: 
Lecturer of Anesthesia, Intensive Care and Pain Management 
Faculty of Medicine, Ain-Shams University 
 
 
 
 
Faculty of Medicine 
Ain Shams University 
2024 
 
 
 
 

 
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What is already known on this subject? What does this study add? 
Upper gastrointestinal (UGI) endoscopic procedures are uncomfortable and 
stressful for most patients; therefore, they are better performed under sedation to decrease 
pain, anxiety, discomfort and increase patient satisfaction. The ideal drug for procedural 
sedation should have a rapid onset, short duration of action, short recovery time, maintain 
cardiovascular stability and with the least adverse effects. However, this is difficult to 
fulfill in a single agent, so we will compare the efficacy of Propofol in combination with 
either ketamine, dexmedetomidine, or midazolam as sedative agents in adult patients 
undergoing elective UGI endoscopic procedures. 
 
1. INTRODUCTION/ REVIEW                                                                                           
Gastrointestinal endoscopy can be categorized as upper or lower endoscopy 
depending on whether the upper GI tract (esophagus, stomach, duodenum, jejunum) or 
lower GI tract (rectum, colon, and terminal ileum) is examined (Kim, 2023).  
Upper Gastrointestinal (UGI) disorders vary from esophagitis, barrett’s esophagus, 
peptic ulcer, esophageal and/or gastric varices, gastro-duodenal erosions to 
gastrointestinal tumors which include esophageal and gastric tumors (Niimi et al., 2017). 
Such disorders may be asymptomatic or associated with symptoms such as indigestion, 
abdominal pain, hematemesis, acute or chronic anemia, dysphagia and excessive 
vomiting (Akdamar et al., 1986). Sometimes, unexpected symptoms appear suddenly 
with life-threatening complications (Stewart et al., 2014). These disorders require upper 
gastrointestinal endoscopy as a diagnostic and therapeutic procedure that allows doctors 
to image, assess, and treat GI illnesses (Kim, 2023). 
Gastrointestinal endoscopic procedures are a high resource utilization practice with 
persistent need for their increase in the future. As such, Control of our practice and 
implementation of measures to continue to provide high quality and safe endoscopic 
services to our patients is mandatory (De Melo et al., 2021). 
However, anxiety, pain, fear, and digestive tract reactions are challenging and may 
cause compliance problems, adverse cardiovascular and respiratory events with increased 
risk of unwanted injuries during endoscopy (Mogahd et al., 2017). Accordingly, several 
different sedatives and analgesics can be used either singly or combined in 
gastrointestinal endoscopic procedures to achieve appropriate procedural sedation levels 
with the fewest side effects (Tekeli et al., 2020). 
Dexmedetomidine is a highly selective alpha-2 agonist sedative drug that reduces 
endogenous norepinephrine release in the brain and spinal cord (Ryu et al., 2012). It has 
analgesic, sedative, and anxiolytic effects while causing minimal respiratory depression 
than other sedatives (Afonso and Reis, 2012). Yet, it can cause bradycardia, hypotension 
and has prolonged onset time with a variable recovery time (Dhir and Jain, 2023). 

 
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Propofol is another phenolic derivative drug that has both sedative and hypnotic 
effects mediated by the gamma amino butyric acid (GABA) receptor. Its lipophilicity 
allows it to cross the blood-brain barrier quickly providing rapid onset and recovery time. 
Moreover, it has amnestic and anti-emetic properties with limited short-lasting analgesic 
effects. The main disadvantage of propofol is the occurrence of dose-dependent 
respiratory and cardiovascular depression (Raman et al., 2022). 
Ketamine is N-methyl-D-aspartate (NMDA) receptor antagonist sedative drug; a 
unique dissociative anesthetic with analgesic and amnestic properties. It maintains airway 
muscle tone and spontaneous breathing. The main drawbacks of its use are vomiting, 
excessive salivation, sympathomimetic effects and significant psychotic emergent 
reactions (Bhavani, 2016). 
Midazolam is a positive allosteric modulator of γ-aminobutyric acid (GABA) type 
A receptors which suppresses neuronal excitability. It is a fast-acting benzodiazepine 
with a short duration of action (Rogawski et al., 2004). It has strong ataraxia, potent 
amnestic, and sedation effect. However, these sedative and amnestic effects sometimes 
do not provide adequate patient comfort during more sophisticated interventional 
procedures, Also it induces respiratory depression and has slow patient recovery time 
(Reimann et al., 2000). 
When used individually, sedatives have known specific limitations and multiple 
adverse effects, especially when used at high doses to achieve deep sedation (Devlin et 
al., 2010). Accordingly, their use in combination may reduce the need for dose escalation 
of a single agent and subsequently the risk of dose-related adverse events, such as 
propofol respiratory and cardiovascular depression, emergent reactions with ketamine or 
severe bradycardia and hypotension with dexmedetomidine (Hemphill et al., 2019). 
Low-dose midazolam in combination with propofol is an effective and economical 
alternative to benzodiazepine-based analgosedation. It is associated with a high degree of 
patient comfort and rapid recovery times and has a potential cost benefit concerning 
nursing care and bed facilities (Reimann et al., 2000). 
Moreover, studies showed that the combined use of ketamine and propofol 
(Ketofol) reduced the required amount of propofol and consequently induced hypotension 
and respiratory depression due to Ketamine`s sympathomimetic effect. Additionally, 
propofol relieved hallucinations and vomiting associated with ketamine due to its 
anxiolytic and antiemetic properties. Therefore, employing this combination has many 
advantages such as favorable recovery time, preserving airway patency, keeping the 
patient spontaneously breathing, stabilizing the hemodynamic profile, and importantly 
reducing the adverse effects associated with both drugs (Amer et al., 2020). 
Similarly, combining propofol with dexmedetomidine allows for deeper sedation 
levels, despite the sympatholytic effects of both agents, it showed favorable effects with 
better stable hemodynamics, better sedation level, preservation of saturation, better 
recovery, and fewer side effects (Tekeli et al., 2020). 

 
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2. AIM/OBJECTIVES 
To compare the efficacy of ketamine-propofol, dexmedetomidine-propofol and 
midazolam-propofol combinations as procedural sedative agents for adult patients 
undergoing elective upper gastrointestinal endoscopic procedures. 
 
3. METHODOLOGY: 
Patients and Methods/ Subjects and Methods/ Material and Methods 
 Type of Study: A prospective, randomized, comparative, single-center, double-
blinded, interventional clinical trial study.  
 Study Setting: Internal medicine endoscopy unit in Ain Shams University Hospitals, 
Cairo, Egypt. 
 Study Period: 1 year after approval of the ethical committee of the faculty of 
medicine, Ain Shams University. 
 Study Population: 75 patients will be endorsed as follows:  
Inclusion Criteria: 
● Both male and female patients aged between 18 and 65 years  
● Patients who are scheduled for elective upper gastrointestinal endoscopic 
procedures with sedation. 
● Patients who are classified as ASA (American Society of Anesthesiologists) I and II  
Exclusion Criteria: 
● Patient refusal to participate 
● Respiratory compromise as patients with respiratory failure or with active chest 
condition e.g. bronchial asthma or pneumonia 
● Cardiovascular compromise including heart failure and shocked patients  
● Severe uncontrolled hematemesis with shock or risk of aspiration. 
● Patients who are allergic or have any contraindications to any of the used drugs. 
● Patients who have a chronic neuropsychiatric disorder or on a neuropsychiatric 
drug.  
● Patients on long-term sedative medication, have a history of drug or alcohol abuse. 
● Pregnancy and lactation 
 Sampling Method: Simple random sampling 
 

 
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 Blinding: 
Both the patient and the endoscopist will be blinded to the intervention. 
The anesthesiologist who will be the primary investigator will not be blinded to the 
groups to allow professional case management throughout the procedure, however, an 
expert anesthesiologist who will also be blinded to the study will be assigned to 
document all the data outcomes of the procedure to prevent bias. 
 Sample Size: Using G power software for sample size calculation: setting power at 
80% and α error at 5%, it is estimated that a sample size of 66 patients undergoing 
elective upper gastrointestinal endoscopic procedures (22 patients receiving 
ketamine-propofol, 22 patients receiving dexmedetomidine-propofol, and 22 patients 
receiving midazolam-propofol combinations) will be needed to detect a statistically 
significant difference between the three groups as regards the recovery time in 
minutes, assuming a large effect size (f=0.40) regarding )Tekeli et al., 2020( using F 
test (ANOVA: fixed effects, omnibus, one-way).  
Assuming that the dropout is of 10%, a sample size of at least 75 patients 
undergoing elective upper gastrointestinal endoscopic procedures (25 patients per 
group) will be needed. 
Ethical Considerations: The procedure will be done under the supervision of the 
main supervisor and by an expert. The study will be performed after approval from the 
Research Ethical Committee (REC), Faculty of Medicine, Ain Shams University. 
Informed and written consent will be obtained from all participants before starting the 
study. The study protocol will be explained to the participants before taking their consent 
to participate in the study.  
 Study Tools: 
All the used interventional medications are approved by the Food and Drug 
Administration (FDA) and the Pharmacy and Therapeutics Committee (PTC) of Ain 
Shams University Hospitals.   
-Ketamine: KetamR 10mls sterile vial (i.e.50mg/1ml), Egyptian International 
Pharmaceuticals Industries Company (EPICIO), Egypt.   
-Propofol: PropofolR 1% 20 mls ampoule (i.e. 10mg/1ml), MCT Fresenius Kabi, 
Egypt. 
-Dexmedetomidine Hydrochloride: PrecedexR 200 µg/2ml vial (i.e.100 µg/1ml), 
Pfizer, Egypt. 
-Midazolam: MidatheticR   5mg/1ml ampoule, Amoun, Egypt. 
-Standard nasal cannula: KyolingR, adult size, single patient use nasal cannula. 
-Monitor: Creative Medical UP-7000Monitor, Shenzhen Creative IndustryCo., Ltd, 
Shenzhen, China 

 
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-Endoscopy: PentaxR Medical EPK-i5000 High Resolution Video Process. 
 Study Procedures and Intervention: 
Consented and enrolled 75 patients will be randomly assigned to one of the 
following three groups: 
1. Group (1): which is Dexmedetomidine-Propofol group (n = 25) 
2. Group (2): which is Ketamine-Propofol (Ketofol ) group (n = 25) 
3. Group (3): which is Midazolam-Propofol  group (n = 25) 
A. Preoperative settings: 
All patients will be fasting for 8 hours. All patients will have their medical and 
anesthetic history taken with a full physical examination. Revision of radiological images 
and routine investigations including CBC, coagulation profile, electrolytes, kidney, and 
liver profiles will be done.  
B. Intraoperative settings: 
-Standard ASA monitoring as electrocardiogram (ECG) for heart rate (beats/min), pulse 
oximetry for (SpO2 as a percentage) and non-invasive blood pressure (NIBP) 
(mmHg), to record baseline data and follow up throughout the procedure. 
- A nasal prong will be connected to the patient with an oxygen flow rate of 3 liter/min. 
Then, a 20 G peripheral venous cannula will be inserted and intravenous (iv) Ringer’s 
solution 8 ml/kg/hr will be started. 
- Diluted 4mg ondansetron will be given slowly iv as an antiemetic premedication. 
-After positioning the patient in the left lateral position, all UGI endoscopic procedures 
will be performed by an accredited gastroenterologist, neither the endoscopist nor the 
patient know the study drugs. Anesthetic care will be provided by an accredited 
specialist anesthesiologist. After confirming the readiness of the endoscopist, all 
patients will undergo deep sedation under monitored anesthetic care (MAC) 
according to the assigned group: 
➔ Patients assigned to (Group 1) will be injected as follows: 
Dexmedetomidine infusion syringe (50mls): will be filled with 2mls of 
dexmedetomidine (200µg) diluted in 48 ml of 0.9% normal saline to make a final volume 
of 50mls and a final dexmedetomidine concentration of 4µg/ml. It will be infused as 1µg 
/kg/hr iv. 
Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol 
(200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final 
propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 
minutes, then infused at a rate of 0.5mg/kg/hr. 
 

 
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➔ Patients assigned to (Group 2) will be injected as follows:   
Ketamine infusion syringe (50mls): will be filled with 2mls of ketamine (100mg) 
diluted in 48mls 0.9% normal saline to make a final volume of 50mls to reach a final 
ketamine concentration of 2mg/ml. It will be administered as a bolus dose of 0.25 mg/kg 
iv then infused at a rate of 0.25mg/kg/hr. 
Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol 
(200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final 
propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 
minutes, then infused at a rate of 0.5mg/kg/hr. 
➔ Patients assigned to (Group 3) will be injected as follows:   
 Midazolam infusion syringe (50mls): will be filled with 10mls of Midazolam 
(50mg) diluted in 40mls 0.9% normal saline to make a final volume of 50mls to reach a 
final midazolam concentration of 1mg/ml. It will be administered as a bolus dose of 0.05 
mg/kg iv over 2 minutes then infused at a rate of 0.025mg/kg/hr. 
Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol 
(200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final 
propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 
minutes, then infused at a rate of 0.5mg/kg/hr. 
All patients will be targeted to reach a level of deep sedation defined as Ramsay 
sedation scale (RSS) score of ≥ 4. RSS will be assessed every 5 minutes throughout the 
procedure till its end. In the case of RSS score is < 4 or if the patient shows limb 
movement at any time within the procedure, rescue propofol doses of 20 mg iv 
increments will be given. 
●Ramsay Sedation Scale: 
Score 
Response 
1 
Awake and anxious, agitated or restless. 
2 
Awake, cooperative, accepted ventilation, oriented, or tranquil 
3 
Awake, responds only to commands  
4 
Asleep, brisk response to light, glabellar tap or loud noise 
5 
Asleep, sluggish response to light, glabellar tap or loud noise 
6 
Asleep, no response to light, glabellar tap or loud noise 
 (Ramsay et al., 1974) 
-Upper gastrointestinal diagnostic and therapeutic endoscopy will be performed by 
PentaxR Medical EPK-i5000 High Resolution Video Process. Therapeutic 
gastroscopy will include variceal band ligation, and endoscopic haemostasis as 
injection of bleeding peptic ulcers with adrenaline or bleeders control via either 
argon plasma coagulation (APC) or heater probe coagulation. 
 

 
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-Any hemodynamic instability will be managed as per the standard guidelines. Any 
incidence of bradycardia (HR<50 beats/min), tachycardia (HR > 20% of baseline 
values), or hypotension (MAP < 60 mmHg) will be managed by requesting the 
endoscopist to cease the procedure till atropine 0.01 mg/kg is given to treat 
bradycardia, or an extra bolus dose of propofol to increase the depth of sedation and 
analgesia to treat tachycardia. However, if hypotension is encountered, it will be 
treated by giving 250 ml of I.V. crystalloids bolus and if no improvement I.V. 
ephedrine 6 mg will be given. 
 
C. Postoperative settings: 
After the procedure is over and the drug infusions are stopped, patient will be 
transferred to the PACU and connected to Standard monitoring as electrocardiogram 
(ECG), pulse oximetry and non-invasive blood pressure (NIBP) (mmHg), to record data 
upon arrival to PACU and to calculate his modified Aldrete score at which patient will be 
discharged when his score is ≥9.               
●Modified Aldrete Score: 
Criteria 
Characteristics 
Points 
Activity 
(Able to move voluntarily or on command) 
Able to move 4 extremities 
2 
Able to move 2 extremities 
1 
Unable to move extremities 
0 
Respiration 
Able to breathe deeply and cough freely 
2 
Dyspnea or limited breathing 
1 
Apneic 
0 
Circulation 
BP +/- 20% of pre-anesthetic level 
2 
BP +/- 20-49% of pre-anesthetic level 
1 
BP +/- 50% of pre-anesthetic level 
0 
Consciousness 
Fully awake 
2 
Arousable on calling 
1 
Not responding 
0 
Oxygen Saturation 
Able to maintain O2 saturation >92% on room air 
2 
Needs oxygen to maintain O2 saturation >90% 
1 
O2 saturation>90% even with supplemental oxygen 
0 
(Aldrete, 1995) 
♦ Measurements and Data collection: 
●Demographic data as:  
-Age (years), sex (m/f), body mass index (BMI) derived from body weight and height 
as (Kg/m2), ASA (I and II). 
 

 
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●Vital Data:  
Peripheral oxygen saturation (SPO2) (oxygen %) measured by pulse oximetry 
during the procedure, Mean arterial pressure (MAP)(mmHg), systolic blood pressure 
(SBP) (mmHg), diastolic blood pressure (DBP) (mmHg), heart rate (HR)(beats/min) will 
be recorded at the baseline, after the induction of sedation and every 5 min until the end 
of the procedure. and upon transferal to the PACU till the patient has modified Aldrete 
score ≥9 and ready for discharge. 
●Outcomes: 
●The primary outcome: will be: 
1-Induction time (Minutes):  
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score. 
2-Recovery time (Minutes):  
The time from the stoppage of the drug infusions till achieving a score of≥9 
according to the modified Aldrete score. 
●Secondary outcomes:  
1-Hemodynamic Parameters. 
Mean arterial pressure (MAP)(mmHg), systolic blood pressure (SBP) (mmHg), 
diastolic blood pressure (DBP) (mmHg), heart rate (HR)(beats/min). and Peripheral 
oxygen saturation (SPO2) (oxygen %).  
2-Ramsay Sedation Scale  
All patients will be targeted to reach a level of deep sedation defined as Ramsay 
sedation scale (RSS) score of ≥ 4.  RSS will be assessed every 5 minutes throughout the 
procedure till its end. 
3-Endoscopist 
satisfaction: 
Endoscopist 
assessment 
of 
the 
sedation 
as 
excellent/good/not bad/bad  
4-Endoscopy procedure time (minutes): The duration of time the endoscope entered 
until exited the oral orifice. 
5-Rescue propofol total doses (mg): In the case of RSS<4 or if the patient shows limb 
movement at any time within the procedure, propofol 20 mg iv increments will be 
given and total given doses in mg will be recorded 
6-Sedation-related adverse effects (SRAEs) and complications: 
Any incidence of respiratory (e.g. apnea, desaturation) or hemodynamic 
compromise (e.g hypotension, bradycardia, tachycardia, arrhythmia, cardiac arrest) or 
any other adverse effects (e.g. nausea, vomiting, allergy, seizure, recovery agitation, and 

 
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delayed recovery) will be managed accordingly and documented. 
 Statistical analysis: all data will be recorded, analyzed, and statistically compared 
between the three groups to identify any significant differences between them.  
 Statistical Methods: The collected data will be revised, coded, tabulated, and 
introduced to a PC using a reliable software program. Data will be presented, and 
suitable analysis will be done according to the type of data obtained for each 
parameter. Data will be tested first for normality. 
 Statistical tests: The collected data will be revised, coded, tabulated, and introduced 
to a PC using a reliable software program. Data will be presented and suitable 
analysis will be done according to the type of data obtained for each parameter. 
1-Descriptive Statistics: 
-Mean Standard deviation (SD) and range for parametric numerical data. 
-Frequency and percentage for non-numerical data. 
2-Analytical Statistics: 
Analysis of variance (one-way ANOVA) will be conducted to assess the statistical 
mean difference between the three groups. If the test shows a significant difference 
between the groups Independent sample t-test will be used to assess the statistical 
significance of the difference of a parametric variable between two independent means of 
the two tests and Chi-squared test will be used for categorical data. 
Probability (P-value): 
P-value ≥0.05 will be considered non-significant 
P-value <0.05 will be considered significant 
P-value <0.001 will be considered highly significant. 
 
 
 
 
 
 
 

 
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