| CTRI Number |
CTRI/2024/10/075725 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| 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 compare the attenuation of hemodynamic response during laryngoscopy and suppression of stress response during laproscopic cholecystectomy surgery in patients who are premedicated with oral clonidine versus oral atenolol |
|
Scientific Title of Study
|
Attenuation of hemodynamic response of laryngoscopy and suppression of stress response during laproscopic cholecystectomy in patients premedicated with oral clonidine versus oral atenolol:A Prospective Randomised Placebo 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 |
Kumari Sonali |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology RIMS Bariatu Ranchi Jharkhand INDIA
Ranchi
JHARKHAND
834009
India |
| Phone |
6207334277 |
| Fax |
|
| Email |
dr.sonalirims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ekramul Haque |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology RIMS Bariatu Ranchi Jharkhand India
Ranchi
JHARKHAND
834009
India |
| Phone |
9431101186 |
| Fax |
|
| Email |
ekramrims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Sinha |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology RIMS Bariatu Ranchi Jharkhand India
Ranchi
JHARKHAND
834009
India |
| Phone |
7860337418 |
| Fax |
|
| Email |
dr.niteshsinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences,Bariatu,India,Pin:834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Bariatu,Ranchi,India,Pin:834009 |
| 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 |
| DrKumari Sonali |
DEPARTMENT OF GENERAL SURGERY ,2ND FLOOR,RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
BARIATU,RANCHI,JHARKHAND,INDIA,PIN:834009
Ranchi
JHARKHAND |
6207334277
dr.sonalirims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Certificate from Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the attenuation of hemodynamic response to laryngoscopy and suppression of stress response during laproscopic cholecystectomy in patients premedicated with oral clonidine versus oral atenolol |
One group will be given Tablet Atenolol 25mg and other group will be given Tablet Clonidine 0.1mg 4 hours before surgery.Patients will be monitored for 24 hours postoperatively |
| Comparator Agent |
To see attenuation of hemodynamic response to laryngoscopy and suppression of stress response during laproscopic cholecystectomy in patients premedicated with oral clonidine versus oral atenolol |
Another group will be given a placebo tablet 4 hours before surgery.Patients will be monitored for 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & ASA II, normotensive patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
ASA III & IV , Hypersensitivity to Atenolol or clonidine SBP less than 100 mmhg heart rate less than 60 per min & more than 120 per min recent myocardial infarction coronary artery disease conduction defect obstructive airway disease second or third degree heart block patient already on antihypertensive medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare perioperative hemodynamic changes in heart rate and blood pressure
To compare the requirement of additional beta blockers |
Perioperative changes in heart rate and blood pressure will be monitored at baseline, at the time of receiving drug, when patient is shifted to OT, at intubation and then at 3 minute intervals till 15 minutes post intubation, then at every 15 minutes till extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare postoperative recovery
To compare postoperative nausea and vomiting
To study post operative pain scores and total dose of rescue analgesia |
1 hour
4 hour
8 hour
12 hour
16 hour
20 hour
24 hour |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
30/10/2024 |
| 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
|
Laryngoscopy and intubation are potent stressful stimuli and lead to various hemodynamic responses like increase in heart rate blood pressure Pneumoperitoneum created during laproscopic surgeries also lead to various stress responses These changes are harmful for certain patients like those with hypertension coronary artery disease heart blocks geriatric population So in order to attenuate these stress responses we have certain drugs like alpha agonists beta blockers benzodiazepines calcium channel blockers Alpha 2 agonists like clonidine decrease blood pressure by decreasing sympathetic tone and reducing circulating catecholamines They also have analgesic effects Beta blockers like atenolol also inhibit sympathetic stimulation and are used to attenuate the stress response The purpose of this study is to compare the perioperative hemodynamic changes in heart rate and blood pressure and to compare the requirement of additional beta blockers |