| 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
|
|
|
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
|
|
|
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. |