| CTRI Number |
CTRI/2025/08/093287 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Ropivacaine Alone vs. Ropivacaine with Dexmedetomidine for Pain Relief After Laparoscopic Gallbladder Surgery: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of intraperitoneal instillation of Ropivacaine with and without dexmedetomidine for post-operative analgesia in laparoscopic cholecystectomy: A randomised 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 Mayank Chauhan |
| Designation |
pg resident |
| Affiliation |
Maharaja Agrasen Medical College, Agroha, Hisar |
| Address |
room no 39 , OP Jindal hostel,Maharaja Agrasen Medical College, Agroha , hisar
Gurgaon
HARYANA
125047
India |
| Phone |
9650978274 |
| Fax |
|
| Email |
mayankchauhan9875@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra Kanojiya |
| Designation |
Professor |
| Affiliation |
Maharaja Agrasen Medical college , Agroha |
| Address |
Room no 120
Department ofanaesthesia ,Maharaja Agrasen Medical college , Agroha
Hisar
HARYANA
125047
India |
| Phone |
8307994393 |
| Fax |
|
| Email |
Drsumitrakanojiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra Kanojiya |
| Designation |
Professor |
| Affiliation |
Maharaja Agrasen Medical college , Agroha |
| Address |
Room no 120
Department ofanaesthesia ,Maharaja Agrasen Medical college , Agroha
Hisar
HARYANA
125047
India |
| Phone |
8307994393 |
| Fax |
|
| Email |
Drsumitrakanojiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia ,Maharaja Agrasen Medical college , Agroha , Hisar |
|
|
Primary Sponsor
|
| Name |
Dr Mayank Chauhan |
| Address |
Room no 39 OP Jindal hostel , Maharaja Agrasen Medical College, Agroha, Hisar |
| Type of Sponsor |
Other [Self] |
|
|
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 Mayank |
Maharaja Agrasen Medical college |
Department ofanaesthesia ,Maharaja Agrasen Medical college , Agroha
Hisar
HARYANA |
9561908452
Mayankchauhan9875@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for human reserch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
80 |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Dr Mayank Chauhan | Compare the post operative pain in 2 groups [ropivacaine vs ropivacaine and dexmeditomidine] in laptoscopic cholecystectomy |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA CLASS 1 AND 2
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare Post operative pain score between two groups |
compare Post operative pain score between two groups at time till 0 hrs , 1 hr ,2 hrs,4 hrs , 8 hrs, 12 hrs and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative adverse effects like bradycardia , hypotension, nausea and vomiting |
Post operative adverse effects will be monitored till 1 hr, 2 hrs , 4 hrs, 8 hrs , 12hrs ,24 hrs |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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 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
|
N/a |