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CTRI Number  CTRI/2026/03/106737 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 21/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Breathing changes during Endoscopic procedure using two different medicines 
Scientific Title of Study   A comparative study of sedation and respiratory effects during endoscopic retrograde cholangiopancreatography with propofol fentanyl versus dexmedetomidine ketamine 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prerana Nirav Shah 
Designation  Professor 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Rhea Kapur 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  8527645446  
Fax    
Email  rheakapur98@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rhea Kapur 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  8527645446  
Fax    
Email  rheakapur98@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India 
 
Primary Sponsor  
Name  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rhea Kapur  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
8527645446

rheakapur98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl Propofol  FENTANYL 1 to 2 mcg/kg IV PROPOFOL 1 to 2 mg/kg IV followed by 1.5 to 4.5 mg/kg/hr infusion started on the lowest rate and titrated as needed  
Comparator Agent  Ketamine Dexmedetomidine  KETAMINE 0.5 mg/kg IV DEXMEDETOMIDINE 0.5 to 1 mcg/kg IV loading dose over 10 minutes IV followed by 0.2 to 0.5 mcg/kg infusion  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients belonging to ASA physical status I (normal Healthy patient) and II (Patient with mild systemic disease). Patients posted for endoscopic retrograde cholangiopancreatography. Patients giving written informed consent to participate in the study. Patients belonging to the age group of 18 to 65 years, of both genders. Patients with a Body Mass Index (BMI) less than 35. 
 
ExclusionCriteria 
Details  Patients with known or suspected obstructive sleep apnoea. Patients who are intubated prior to the procedure, or needing oxygen supplementation on a daily basis. Patients with a history of allergies to the study medications or their ingredients. Female patients who are pregnant or lactating.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare sedation and respiratory effects in patients undergoing endoscopic retrograde pancreaticography with Propofol Fentanyl versus Dexmedetomidine Ketamine.  at the end of the procedure, and every 10 minutes thereafter till 30 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To compare haemodynamic parameters (heart rate, mean arterial pressure) between the two groups.
To compare the time to recovery using the Modified Aldrete Score.
To compare post-procedural pain using the Numeric Rating Scale for pain.
To compare the incidence of adverse events, including hypoventilation, apnoea, oxygen desaturation, hypotension, bradycardia, and requirement of airway interventions
 
at the end of the procedure, and every 10 minutes thereafter till 30 minutes 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This prospective observational study aims to compare the sedation and respiratory effects of two intravenous sedative regimens that is, Propofol Fentanyl versus Dexmedetomidine Ketamine, in adult patients undergoing Endoscopic Retrograde Cholangiopancreatography or ERCP at KEM Hospital, Mumbai.

ERCP is a complex, prone positioned gastrointestinal procedure that requires deep sedation to suppress airway reflexes and ensure patient immobility. Traditionally, Propofol combined with Fentanyl is used, offering rapid onset and recovery but often associated with respiratory depression and haemodynamic instability. Alternatively, the Dexmedetomidine and Ketamine combination offers a favourable safety profile as dexmedetomidine provides sedation and analgesia with minimal respiratory depression, while ketamine preserves airway reflexes and counters haemodynamic side effects.

The study will include 80 adult patients belonging to ASA I and II category, aged 18 to 65 years, with BMI less than 35, and will exclude patients with sleep apnoea, significant respiratory disease, pregnancy, or drug allergies. Patients will receive oxygen via nasal cannula, and be monitored using standard ASA parameters along with end tidal CO2 etCO2 for real time ventilation assessment. Parameters like heart rate, mean arterial pressure MAP, oxygen saturation SpO2, sedation depth by the Ramsay Sedation Scale, recovery by the Modified Aldrete Score, pain by the Numeric Rating Scale, and adverse events for example, hypoventilation, apnoea, desaturation, hypotension, bradycardia etcetera will be recorded at defined intervals intra procedure and post procedure.

The primary objective is to compare sedation and respiratory outcomes SpO2, etCO2 between the Propofol Fentanyl and Dexmedetomidine Ketamine groups. Secondary objectives include comparing haemodynamic stability, time to achieve desired sedation depth, recovery time, pain scores, and adverse event rates.

Statistical analysis will involve chi square test, Fischer’s exact test and for means of more than two groups, one way ANOVA test. Significance is set at p less than 0.05.

The study aims to determine which regimen provides safer, more effective sedation with fewer complications during ERCP, ultimately guiding optimal anaesthetic practice for this high risk procedure.

 
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