| CTRI Number |
CTRI/2025/01/079642 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effectiveness of oral clonidine as a premedication on intraoperative hemodynamic response for patients undergoing laproscopic cholecystectomy- A Single Blinded Randomised Control Study
|
|
Scientific Title of Study
|
Effectiveness of oral clonidine as a premedication on intraoperative hemodynamic response for patients undergoing laproscopic cholecystectomy- A Single Blinded Randomised Control Study
|
| 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 KARTIK RAJGOPAL L |
| Designation |
Resident |
| Affiliation |
Sri Ramachandra medical college and research hospital |
| Address |
Department of Anaesthesia,
Sri Ramachandra medical college and research hospital,
Porur
Chennai
TAMIL NADU
600011
India |
| Phone |
9677118206 |
| Fax |
|
| Email |
karshylak1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYARAMAN V |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra medical college and research hospital |
| Address |
Sri Ramachandra medical college and research hospital, Sri Ramachandra university, Porur, Chennai-600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841219820 |
| Fax |
|
| Email |
vjram2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
KARTIK RAJGOPAL L |
| Designation |
Resident |
| Affiliation |
Sri Ramachandra medical college and research hospital |
| Address |
Department of anesthesiology,
Sri Ramachandra medical college and research hospital,
Porur,
Chennai
TAMIL NADU
600011
India |
| Phone |
9677118206 |
| Fax |
|
| Email |
karshylak1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra medical college and researchhospital, porur, chennai-600116. |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Sri Ramachandra University, Porur, Chennai-600116. |
| 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 |
| KARTIK RAJGOPAL L |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
Department of Anesthesiology,
Sri Ramachandra medical college and research hospital Porur, Chennai-600116
Thiruvallur
TAMIL NADU |
9677118206
karshylak1996@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: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hemodynamic response and postoperative analgesic requirement |
Premedication with oral clonidine 100mcgs versus vitamin C 1 hour before surgery to assess intraoperative hemodynamic response and postoperative analgesic requirement at 30 mins, 60 mins, 90 mins and 120 mins |
| Comparator Agent |
Oral clonidine versus oral vitamin C |
Oral clonidine 100mcgs versus oral vitamin C premedication 1 hour before surgery to assess intraoperative hemodynamic response and postoperative analgesic requirement. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grading 1 and 2
Elective laproscopic surgery under general anaesthesia.
BMI less than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
Patient refusal for consent.
ASA grading more than 3.
BMI more than 30kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative hemodynamic response( HR, BP, MAP, sevoflurane concentration, total vasopressors used, total amount of fluids given) |
Baseline, 1 min after intubation, 5mins after intubation, time of skin incision, at time of pneumoperitoneum, 15 mind after pneumoperitoneum, 15mins after release of pneumoperitoneum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative analgesic requirement
VAS SCORES
RAMSAY SEDATION SCORE |
30 mins, 60 mins, 90 mins, 120 mins postoperative period |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/02/2025 |
| Date of Study Completion (India) |
16/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Premedication with oral clonidine suppresses the stressor hormones like catecholamines, cortisol released by laryngoscopy , insertion of laparoscopic ports and provides proper surgical conditions. It also used as analgesic and sedative which improves post operative recovery. Our study is to evaluate effectiveness of oral clonidine in attenuation of hemodynamic responses in laparoscopic cholecystectomy surgeries |