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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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult patients with ASA 1and 2 physical status scheduled for cardiac surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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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