| CTRI Number |
CTRI/2025/10/096512 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Remifentanil and Fentanyl with AutoFlow mode of ventilation in Laparoscopic surgery |
|
Scientific Title of Study
|
Remifentanil versus Fentanyl along with Autoflow ventilation in Laparoscopic surgery: A Randomized controlled trial |
| 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 Carolin Smita Kerketta |
| Designation |
ASSOCIATE 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
Ahmadabad
GUJARAT
380025
India |
| Phone |
9904451321 |
| Fax |
|
| Email |
carolinsmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Carolin Smita Kerketta |
| Designation |
ASSOCIATE 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
Ahmadabad
GUJARAT
380025
India |
| Phone |
9904451321 |
| Fax |
|
| Email |
carolinsmita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Carolin Smita Kerketta |
| Designation |
ASSOCIATE 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
Ahmadabad
GUJARAT
380025
India |
| Phone |
9904451321 |
| Fax |
|
| Email |
carolinsmita@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS medical college hospital and research centre opposite DRM office Naroda Road Ahmedabad Gujarat India 380025 |
|
|
Primary Sponsor
|
| Name |
GCS Hospital |
| Address |
GCS Medical College Hospital and Research Centre Anaesthesia Department 53 Opposite DRM office Naroda Road Ahmedabad |
| Type of Sponsor |
Private 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 carolin Smita Kerketta |
GCS Medical college hospital and research centre |
Anaesthesia Department 53
Ahmadabad
GUJARAT |
07966048000
carolinsmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (Biomedical & Health Research) EC/NEW/INST/2021/GJ/0009 |
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 |
inj Remifentanil and inj Fentanyl with AutoFlow ventilation |
Remifentanil iv Bolus 1mcg per Kg followed by infusion dose zero point1 mcg per kg per min with AutoFlow ventilation mode
Fentanyl iv bolus 2mcg per Kg followed by infusion dose zero point 5 mcg per kg per hr with AutoFlow ventilation mode |
| Comparator Agent |
To compare inj Remifentanil and inj Fentanyl with Autoflow mode of ventilation |
To see PIP haemodynamic status time to extubation post operative pain score and rescue analgesia requirement in both groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years ASA grade I and II Elective Laparoscopic surgeries and BMI less than 35 Kg per meter square |
|
| ExclusionCriteria |
| Details |
BMI more than 35 Kg per meter square ASA grade III IV and V Emergency surgeries Pregnancy and Allergies to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see PIP haemodynamic status time to extubation post operative |
At Baseline 15min 30 min 45 min 60 min 90 min 120 min after induction of anaesthesia
At extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess time of extubation post operative pain score and rescue analgesia requirement |
Pain score at time of extubation 6 hour after extubation 12 hour and 24 hour after extubation analgesic requirement in 24 hours after surgery |
|
|
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)
|
15/11/2025 |
| 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="1"
Months="0"
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
|
To compare Remifentanil and AutoFlow Ventilation with standard Fentanyl and Conventional Volume-Controlled ventilation in Laparoscopic Surgeries. A prospective, randomized, controlled trial
Written and informed consent will be obtained.
Patients of ASA Grade I & II posted for elective laparoscopic surgeries to be included & randomly divided into two equal groups of 50 each.
Group A (n=50): Remifentanil i AutoFlow ventilation mode
Group B (n=50) Fentanyl iv bolus 2mcg/Kg followed by infusion dose - 0.5 mcg/kg/hr
Conventional volume-controlled ventilation |