| CTRI Number |
CTRI/2022/03/041080 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
15/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of oral clonidine premedication on intraoperative vital stability for patients undergoing laparoscopic cholecystectomy
|
|
Scientific Title of Study
|
Effect of oral clonidine premedication on perioprative hemodynamic response for patients undergoing 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 |
Dr Reena Verma |
| Designation |
Junior resident |
| Affiliation |
Rnt medical college and mb hospital udaipur rajasthan |
| Address |
Department of anaesthesia Rnt medical college and mb hospital udaipur rajasthan
Department of anaesthesia Rnt medical college and hospital udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
07300312714 |
| Fax |
|
| Email |
vreena112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena Verma |
| Designation |
Junior resident |
| Affiliation |
Rnt medical college and mb hospital udaipur rajasthan |
| Address |
Rnt medical college and mb hospital udaipur rajasthan
Department of anaesthesia Rnt medical college and hospital udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
07300312714 |
| Fax |
|
| Email |
vreena112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr khemraj meena |
| Designation |
Senior professor |
| Affiliation |
Rnt medical college and mb hospital udaipur rajasthan |
| Address |
Rnt medical college and mb hospital udaipur rajasthan
Rnt medical college and mb hospital udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
khemraj10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
Rnt medical college and hospital udaipur rajasthan |
| Type of Sponsor |
Government 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 Reena Verma |
Rnt medical college and hospital udaipur |
2 nd floor main surgery ot department of anaesthesia
Udaipur
RAJASTHAN |
7300312714
vreena112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Rantac 100mg |
Tab Rantac 100mg given 90 minuts before induction |
| Intervention |
Tablet clonidine 100 microgram |
Group 1- tab clonidine 100mcg
Group 2- placebo (tablet Rantac 100mg ) given 90 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of ASA grade 1-2
2) Patients of both sex
3) Patients in age group 18-60 years
4) Patients scheduled for laparoscopic cholecystectomy surgeries |
|
| ExclusionCriteria |
| Details |
1) Patients not fulfilling eligibility criteria
2) Lack of patient consent
3) Drug dependence
4) History of bronchial asthma
5) Patients allergic to clonidine
6) Hypertensive and diabetic patients
7) Severe coronary insufficiency, recent Myocardial infarction
8) Concomitant use of monoamine oxidase inhibitors, tricyclic antidepressantsor opioids |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
intra-operative haemodynamic parameters.
|
Intraoperatively (90-120 minutes)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain and sedation scores, duration of postoperative analgesia.
Adverse effects
|
24 hours Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2022 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study was designed to evaluate the effects of oral clonidine premedication on heamodynamic response and modulation of post-operative pain in patients undergoing laparoscopic surgeries.4 To compare intra-operative haemodynamic parameters. To compare pain and sedation scores To compare time of first postoperative analgesia To compare adverse effects This prospective randomized, single blind, comparative study was conducted on adult patients undergoing laparoscopic cholecystectomy surgeries |