| CTRI Number |
CTRI/2021/07/034534 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare two drugs Dexmedetomidine and Lignocaine to bring down blood pressure, pulse rate, respiratory rate and airway response to endotracheal extubation after CABG(Coronary Artery Bypass Graft) surgery. |
|
Scientific Title of Study
|
A comparative evaluation of efficacy of Lignocaine and Dexmedetomidine to attenuate Hemodynamic and Airway response to endotracheal extubation in elective post operative CABG surgery: A prospective randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mithilesh Kumar |
| Designation |
Junior Resident(academic) |
| Affiliation |
IGIMS, Patna |
| Address |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,
SHEIKHPURA, BAILEY ROAD RAZABAZAR,PATNA,BIHAR
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
mithileshpmc2k10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithilesh Kumar |
| Designation |
Junior Resident(academic) |
| Affiliation |
IGIMS, Patna |
| Address |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,
SHEIKHPURA, BAILEY ROAD, RAZABAZAR, PATNA, BIHAR
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
mithileshpmc2k10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Additional Professor |
| Affiliation |
IGIMS, Patna |
| Address |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,
SHEIKHPURA,BAILEY ROAD, RAZA BAZAR, PATNA, BIHAR.
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCE PATNA |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE FIRST FLOOR,NEURO OT COMPLEX, IGIMS, PATNA |
| 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 MITHILESH KUMAR |
CTVS complex, INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCE PATNA |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE, IGIMS, PATNA.
Patna
BIHAR |
7979822440
mithileshpmc2k10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE IGIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
0.5 mcg/kg diluted in 10 ml NS given over 60seconds, 5 minute before extubation |
| Comparator Agent |
lignocaine |
1.5mg/kg diluted in 10ml NS given over 60seconds, 5minutes before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1)ASA 2 and 3
(2)Patient undergoing elective CABG Surgery
(3)Mallampati grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
(1)Allergy to studied drug
(2)Patient with significant valvular heart disease
(3)Patient with significant bradycardia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the hemodynamic parameter and airway response |
1,3,5,7 minutes after drug administration
1,3,5,10,15,20 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess sedation status of patient and Airway response in form of coughing brochospadm and laryngospasm |
At extubation and 1,3,5,10,15,20 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/07/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Plan to publish on completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of study is to compare the efficacy of Dexmedetomidine and lignocaine to attenuate(decrease)the hemodynamic and airway response to endotracheal extubation in elective post operative CABG (coronary artery bypass graft) Surgery |