| CTRI Number |
CTRI/2026/02/103486 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two sedation drug combinations in colonoscopy patients to evaluate comfort, safety, and recovery |
|
Scientific Title of Study
|
A Randomised Controlled Double-Blinded Study Comparing Patient Satisfaction and Hemodynamic Responses Between Ketamine-Propofol Combination and Fentanyl-Propofol During Conscious Sedation and Analgesia in Colonoscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshana S |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute for Higher Education and Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra University,
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
919500163631 |
| Fax |
|
| Email |
rakshana26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arul Murugan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute for Higher Education and Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra University,
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
919380537411 |
| Fax |
|
| Email |
Rampond@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAKSHANA S |
| Designation |
PG student |
| Affiliation |
Sri Ramachandra Institute for Higher Education and Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra University,
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
919500163631 |
| Fax |
|
| Email |
rakshana26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rakshana S |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai 600116, Tamil Nadu |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Rakshana S |
Sri Ramachandra Institute of Higher Education and Research |
Department of Gastroenterology, Colonoscopy Room, Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU |
9500163631
rakshana26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K635||Polyp of colon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group PF Propofol Fentanyl combination |
Midazolam 0.01 milligrams per kilogram before induction followed by
Bolus dose of Propofol 0.75 milligrams per kilogram and Fentanyl 1 micrograms per kilogram. Maintained with Propofol infusion 50micrograms per kilogram per minute. Route- Intravenous. Single induction bolus followed by continuous propofol infusion at 50 micrograms per kilogram per minute for the duration of colonoscopy procedure. Duration will be from induction until the end of procedure. |
| Comparator Agent |
Group PK Propofol Ketamine combination |
Midazolam 0.01 milligram per kilogram before induction followed by
Bolus dose of Propofol 0.75 milligram per kilogram and Ketamine 0.5 milligram per kilogram
Maintained with Propofol infusion of 50 microgram per kilogram per minute. Route- Intravenous. Single induction bolus followed by continuous propofol infusion at 50 micrograms per kilogram per minute for the duration of colonoscopy procedure. Duration will be from induction until the end of procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 and older of both gender
Physical status of American Society of Anaesthesiologists ASA grade 1,2
Patients undergoing elective day care colonoscopy procedure
Well controlled hypertensive patients without any recent episode of hypertensive episodes |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction during colonoscopy measured using a five point Likert scale. Where 1 indicates not at all satisfied and 5 indicates extremely satisfied. Assessment will be done after the procedure when the patient is alert and cooperative. |
Once the patient is alert and cooperative in the post anaesthesia care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hemodynamic events. Hypotension defined as a decrease of more than thirty percent from baseline systolic blood pressure. Bradycardia defined as heart rate less than fifty beats per minute |
Intraoperative period- continuous monitoring |
| Incidence of respiratory events. Desaturation defined as oxygen saturation less than ninety two percent. Apnea defined as cessation of breathing for more than twenty seconds |
Intraoperative period- continuous monitoring |
| Incidence of psychological emergence reactions in the post anaesthesia care unit. |
Post anaesthesia care unit- Every 1 minute for the first 5 minutes, then every 5 minutes until discharge |
| Incidence of nausea & vomiting in the post anaesthesia care unit. |
Post anaesthesia care unit-Every 1 minute for the first 5 minutes, then every 5 minutes until discharge |
| Total propofol dose consumed in milligrams from induction to end of procedure. |
Durning the entire Intraoperative period |
| Endoscopist satisfaction rated on a ten point Likert scale. |
5 minutes Post procedure |
| Level of sedation during the procedure assessed every five minutes using Observer’s Assessment of Alertness & Sedation scale. |
Every 5 minutes from the start of the procedure |
| Recovery time defined as the time taken between the end of procedure & achieving a modified Aldrete score of nine or above. |
From end of procedure to discharge from Post anaesthesia care unit |
| Quality of recovery assessed using QoR 15 predesigned questionnaire. |
Once the patient is alert & cooperative in Post anaesthesia care unit |
| Patient recall of intra procedural events such as pain or other experiences |
Once the patient is alert & cooperative in Post anaesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
09/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Colonoscopy is a commonly performed diagnostic procedure that can cause pain and anxiety. Sedation is often used to improve patient comfort and satisfaction. This study aims to compare patient satisfaction and hemodynamic responses during colonoscopy using two different sedation combinations. Adult patients undergoing elective colonoscopy will be randomly allocated into two groups. One group will receive a combination of propofol and ketamine, while the other group will receive propofol and fentanyl for conscious sedation. Hemodynamic parameters such as heart rate blood pressure oxygen saturation and end tidal carbon dioxide will be monitored during the procedure. Patient satisfaction recovery characteristics and adverse events will be assessed after the procedure. The results of this study may help identify an optimal sedation technique for colonoscopy. |