| CTRI Number |
CTRI/2022/08/044818 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2022 |
| 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
|
A STUDY BETWEEN 2 GROUPS TO DETERMINE THE EFFECT
OF CLONIDINE DRUG IN REQUIREMENTS OF INDUCTION
AGENT FOR PATIENTS UNDERGOING CABG SURGERY. |
|
Scientific Title of Study
|
COMPARATIVE OBSERVATIONAL PROSPECTIVE
RANDOMIZED STUDY TO DETERMINE THE EFFECT
OF CLONIDINE AS AN ADJUNCT TO INDUCTION
AGENTS IN PATIENTS UNDERGOING CORONARY
ARTERY BYPASS GRAFTING SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Sarkar |
| Designation |
post graduate resident doctor |
| Affiliation |
DR DY PATIL HOSPITAL NAVI MUMBAI |
| Address |
B3/504 , empire estate ,chinchwad,pune
Thane
MAHARASHTRA
411019
India |
| Phone |
7219031392 |
| Fax |
|
| Email |
rahul.sarkar.rahul123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJULA SARKAR |
| Designation |
PROFESSOR IN CARDIAC ANESTHESIA DEPARTMENT DY PATIL NAVI MUMBAI |
| Affiliation |
DR DY PATIL HOSPITAL NAVI MUMBAI |
| Address |
101,EMPIRE BUILDING,PLOT NO.A5 AZAD NAGAR,VEERA DESAI ROAD ANDHERI(WEST) MUMBAI-58
Mumbai
MAHARASHTRA
400102
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Sarkar |
| Designation |
post graduate resident doctor |
| Affiliation |
DR DY PATIL HOSPITAL NAVI MUMBAI |
| Address |
B3/504 , empire estate ,chinchwad,pune
MAHARASHTRA
411019
India |
| Phone |
7219031392 |
| Fax |
|
| Email |
rahul.sarkar.rahul123@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR DY PATIL HOPSITAL NAVI MUMBAI |
|
|
Primary Sponsor
|
| Name |
Rahul Sarkar |
| Address |
B3/504 , empire estate ,chinchwad,pune |
| Type of Sponsor |
Other [SELF (RAHUL SARKAR)] |
|
|
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 |
| Rahul Sarkar |
D Y Patil Medical College and Hospital |
Department of Anesthesiology
Second floor
D Y Patil Hospital
Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA |
7219031392
rahul.sarkar.rahul123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
Single dose I.V. 4 microgram/kg |
| Comparator Agent |
Normal Saline (0.9% NaCl) |
Single dose I.V. 10 ml |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
â–ª All patient giving consent
â–ª Patients undergoing CABG
â–ª Age 30 -65 yrs.
â–ª Ejection fraction > 40%
â–ª Body Mass Index
â–ª Patients without pulmonary hypertension
â–ª Patients of either sex
â–ª ASA grade II & III |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to get enrolled in the study.
2.Age < 30 yrs and > 65 yrs
3.Ejection fraction < 40%
4.Patients with pulmonary hypertension
5.Valvular heart diseases
6.Pregnant patient
7.Patients with bronchial asthma
8.Patient on treatment with antipsychotic drugs/psychic patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (SBP, DBP, MAP, HR) |
Baseline, Before induction, Before intubation, 5 minutes after intubation, End of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects |
During entire surgery period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2022 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Comparative Observational Prospective Randomized Study will be
conducted in Department of Anesthesiology,
D Y Patil University School of Medicine & Hospital, Nerul, Navi Mumbai. 1) Pre-operative evaluationHistory, PAST History, Clinical Examination, Routine investigations, Stress test, 2
D-ECHO, Coronary Angiography.
2) On the day of surgery, patients will be examined. Volunteers will be allocated
randomly with sealed envelop technique to 2 groups each containing forty
patients each.
• Group A (Clonidine) - Patients will receive i.v. clonidine as a pre-medication
dose of 4 µg/kg in the OT.
• Group B (Placebo) - Patients will receive IV 0.9%Normal Saline of the same
volume in the OT.
— NBM status will be confirmed. — Informed written consent will be taken.
— Pre-operative vitals will be recorded in the form of baseline pulse and blood
pressure.
— After arriving in the OT monitors will be attached- Manual BP cuff, Pulse
oximeter, Temperature Probe, Ecg Chest Leads.
Cardio scope.
Inspired air will be supplemented with oxygen at 5-6 liters/min
— Vein will be canulated with appropriate intracath (16 G or 18 G) on the dorsum
of hand.
— Inj clonidine (4 µg/kg) will be given i.v. over 10 minutes.
— Internal jugular vein will be canulated with triple lumen.
— Radial artery will be canulated for intra-arterial blood pressure monitoring.
— The patient will be induced with inj midazolam (0.1 mg/kg), inj fentanyl
(5-10 µg/kg) and inj Vecuronium (0.1 mg/kg).
The doses of Inj. propofol required will be given and any additional doses if
required during the procedure will be noted.
Maintenance: Sevoflurane (2% ) & Sedation Mixture (Inj. Fentanyl +
Inj. Midazolam + Inj.Vecuronium)
Rescue maintenance required with sevoflurane in the incremental doses 4%- 6%
will be noted.
The following Parameters will be Monitored intraoperatively: ECG, Pulse
Oximetry, EtCO‚ IBP, CVP, Nasopharyngeal Temperature, Serial ABG, ACT. |