| CTRI Number |
CTRI/2025/06/089130 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on Pain Control Methods During Gallbladder Surgery |
|
Scientific Title of Study
|
A Randomised control trial of opioid versus opioid free anesthesia in laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika priya |
| Designation |
Associate professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15,dept of anaesthesia,VMKVMCH,salem
Salem
TAMIL NADU
636308
India |
| Phone |
8129340367 |
| Fax |
|
| Email |
rasikamadhan1985@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15,dept of anaesthesia,VMKVMCH,salem
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rasika priya |
| Designation |
Associate professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15,dept of anaesthesia,VMKVMCH,salem
Salem
TAMIL NADU
636308
India |
| Phone |
8129340367 |
| Fax |
|
| Email |
rasikamadhan1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions kirupanandha variyar medical college and hospitals,Salem-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions kirupanandha variyar medical college and hospitals |
| Address |
Chinnaseragapadi,Salem-636308 |
| 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 Rasika priya |
VMKVMCH |
Room number 15,department of anaesthesiology ,Salem,TAMIL NADU
Salem
TAMIL NADU |
8129340367
rasikamadhan1985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Vinayaka Missions Kirupananda Variyar Medical College and Hospitals ,Salem |
Approved |
| InstitutionalEthicsCommitteeVinayaka Missions Kirupanandha Variyar Medical College Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cholelithiasis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of opioid anaesthesia in laparoscopic cholecystectomy |
patients will receive inj.fentanyl 2mcg/kg over 10mins follwed by 0.5mcg/kg IV till the end of surgery |
| Comparator Agent |
comparison of opioid free anesthesia in laparoscopic surgeries |
patients will receive lignocaine 2mg/kg IV and dexmeditomidine IV 0.5mcg/kgover 10 mins followed by continuous infusion of dexmdetomidne 0.5mcg/kg/hr with inj.lignocaine 2mg/kg/hr IV |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Patients posted for laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Allergic to study medication
Pregnant and lactating woman
Pre existing diseases like cardiopulmonary,liver and renal diseases,psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score using a NRS scale at 2, 6, 12, and 24 hours post-surgery. |
1 min of rescue analgesic requirement in both groups to 2hrs post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of recovery & hemodynamic stability in both groups |
from 0 mins of surgery to ,2 hours post op in both groups |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was done to compare opioid free Anaesthesia and opioid based Anaesthesia in laparoscopic cholecystectomy in terms of time to first rescue analgesic as primary objective and quality of recovery and hemodynamic stability as secondary objective |