| CTRI Number |
CTRI/2025/11/096911 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
use of remifentanil in day care srugeries |
|
Scientific Title of Study
|
fast track anaesthesia with remifentanyl : A Prospective Study in Ambulatory Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Kheskani |
| Designation |
Professor |
| Affiliation |
GCS Medical college Hospital and Research Centre Ahmedabad |
| Address |
GCS medical college hospital and research Centre Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8980738209 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Kheskani |
| Designation |
Professor |
| Affiliation |
GCS Medical college Hospital and Research Centre Ahmedabad |
| Address |
GCS medical college hospital and research Centre Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
GUJARAT
380025
India |
| Phone |
8980738209 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Kheskani |
| Designation |
Professor |
| Affiliation |
GCS Medical college Hospital and Research Centre Ahmedabad |
| Address |
GCS medical college hospital and research Centre Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
GUJARAT
380025
India |
| Phone |
8980738209 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College,hospital and research centre |
|
|
Primary Sponsor
|
| Name |
GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
GCS medical College, Hospital and Research Centre, opp. DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya Kheskani |
GCS medical College, Hospital and Research Centre, |
GCS medical college hospital and research Centre Anaesthesia Department ground floor OT complex 53 opposite DRM Office Naroda Road Ahmedabad
Ahmadabad
GUJARAT |
8980738209
divya.kheskani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GCS medical college, |
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 |
| Comparator Agent |
fenranyl (group F) |
IV bolus :2 µg/kg
Continuous infusion: 0.5 µg /kg/hr, |
| Intervention |
Remifentanil (group R) |
Remifentanil administered as:
IV bolus: 1 µg/kg
Continuous infusion: 0.1 µg /kg/min,
May be combined with low-dose midazolam or propofol as needed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Willing to give consent
ASA Physical Status I or II
Undergoing elective ambulatory surgery |
|
| ExclusionCriteria |
| Details |
Known opioid allergy
ASA 3,4
Severe cardiopulmonary disease
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate hemodynamic stability of remifentanil
To evaluate analgesia and sedation of remifentanil patients
undergoing ambulatory surgeries
To assess the time to recovery and discharge readiness following
remifentanil- |
at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare patient and surgeon satisfaction scores with remifentanil
versus fentanyl
To compare surgeon satisfaction scores with remifentanil versus
fentanyl |
at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/11/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Type: Prospective randomized controlled trial (RCT)
Sample size ..100 or time duration based whatever is greater
Participants: A total of 100 adult patients (ASA I–II) scheduled for elective ambulatory surgeries,
Randomization: Patients were randomly assigned to two groups
Remifentanil Group (Group R n=50): Received remifentanil infusion.
Fentanyl Group (Group F n = 50): Received fentanyl infusion.
INCLUDED Day-care unit or ambulatory surgery center performing procedures such as:
Upper gastrointestinal endoscopy
Colonoscopy
Minor general surgery (e.g., hernia repair, cyst excision)
Gynecological procedures (e.g., D&C, hysteroscopy) |