CTRI Number |
CTRI/2017/11/010355 [Registered on: 02/11/2017] Trial Registered Retrospectively |
Last Modified On: |
10/11/2016 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare the effects of Dexmeditomidine, Esmolol, and combination of both to know the stress response prevention for endotracheal intubation.
|
Scientific Title of Study
|
The comparison of the effects of dexmedetomidine, esmolol and combination of dexmedetomidine with esmolol to attenuate
hemodynamic response to endotracheal intubation in patients
undergoing CABG.
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shio Priye |
Designation |
Professor |
Affiliation |
Vydehi Institute of Medical Sciences and Research Centre |
Address |
Dr Shio Priye, Professor, Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore Dr Shio Priye, Professor,
Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore Bangalore KARNATAKA 560066 India |
Phone |
9986743162 |
Fax |
|
Email |
shiopriye@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shio Priye |
Designation |
Professor |
Affiliation |
Vydehi Institute of Medical Sciences and Research Centre |
Address |
Dr Shio Priye, Professor, Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore Dr Shio Priye, Professor,
Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore Bangalore KARNATAKA 560066 India |
Phone |
9986743162 |
Fax |
|
Email |
shiopriye@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shio Priye |
Designation |
Professor |
Affiliation |
Vydehi Institute of Medical Sciences and Research Centre |
Address |
Dr Shio Priye, Professor, Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore Dr Shio Priye, Professor,
Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore Bangalore KARNATAKA 560066 India |
Phone |
9986743162 |
Fax |
|
Email |
shiopriye@gmail.com |
|
Source of Monetary or Material Support
|
Vydehi Institute of Medical Sciences and Research Centre,#82,EPIP area, Whitefield, Bangalore-560066. |
|
Primary Sponsor
|
Name |
Vydehi Institute of Medical Sciences and Research Centre |
Address |
Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Whitefield, Bangalore |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Dipali Singh |
Department of Anaesthesiology, Vydehi Institute of Medical Sciences, Whitefield, Bangalore |
Dr Durga Prasad Reddy |
Department of Cardiac Surgery, Vydehi Institute of Medical Sciences, Whitefield, Bangalore |
Dr Sathyanarayan jagannath |
Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Whitefield, Bangalore |
Dr Syed Mudassar A |
Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Whitefield, Bangalore |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Shio Priye |
Department of Cardiac Anaesthesiology |
#82, EPIP area, Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bengaluru-66. Bangalore KARNATAKA |
9986743162
shiopriye@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee (EC) Vydehi Institute of Medical Sciences and Research Centre |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Adult patients with ASA 1and 2 physical status scheduled for cardiac surgery, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Adult patients with ASA 1and 2 physical status scheduled for cardiac surgery |
|
ExclusionCriteria |
Details |
Exclusion criteria included anticipated difficult intubation, emergency surgery, left ventricular ejection fraction <40%, left ventricular aneurysm, associated valvular lesions, left main coronary artery disease, severe systemic diseases involving the renal and hepatic systems, preoperative left bundle branch block, chronic obstructive pulmonary disease and intubation attempt lasting longer than 20 seconds. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
attenuation of stress response to endotracheal intubation in terms of heart rate, blood pressure and pulmonary artery pressure |
Hemodynamic variables(heart rate,blood pressure and pulmonary pressure) were recorded baseline, after study drug, after induction before intubation and 1, 3, 5 minute after orotracheal intubation. |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/07/2015 |
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) |
Closed to Recruitment of Participants |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Background and objectives: Laryngoscopy and intubation can cause hemodynamic
response. Various medications may be employed to control that response. In this
study, we aim to compare the effects of dexmedetomidine, esmolol and esmolol
with dexmedetomidine on hemodynamic response.
Methods: Hundred
and twenty elective surgery patients in need of endotracheal intubation, who were
American Society of Anesthesiology I - II group and ages between 21 and 65
years were included in a prospective, randomized, double-blind study. Systolic,
diastolic, mean arterial & pulmonary pressures, heart rates, at the time of
admittance to the operation room were recorded as basal measurements. The
patients were randomized into four groups: Group I (n = 30) received 1 µg/kg
dexmedetomidine, Group II (n = 30) received 2 mg/kg esmolol, Group III (n
= 30) received 0.5 µg/kg dexmedetomidine plus 1 mg/kg esmolol and Group IV (n
= 30) received 1µg/kg dexmedetomidine plus 2mg/kg esmolol with infusion
over a period of 10 min before induction. The patients were intubated 2 min after
induction. Systolic, diastolic, mean arterial & pulmonary pressures and
heart rates were measured at base line, 10 minutes after drug, 2 min after
induction before intubation and 1, 3, 5, min after intubation.
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