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CTRI Number  CTRI/2017/08/009294 [Registered on: 08/08/2017] Trial Registered Retrospectively
Last Modified On: 04/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effects of Macintosh direct laryngoscope versus Glidescope videolaryngoscope on the blood pressure and upper airway injury in patients with high blood pressure during general anaesthesia 
Scientific Title of Study   Comparison of hemodynamic responses and upper airway morbidity following orotracheal intubation in hypertensive patients - Macintosh direct laryngoscope versus Glidescope videolaryngoscope 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vimi Rewari 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Department of Anaesthesiology All India Institute of Medical Sciences,Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9818304880  
Fax    
Email  vimirewari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tanvi Meshram 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Department of Anaesthesiology All India Institute of Medical Sciences,Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9968480167  
Fax    
Email  tanvimeshram162@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vimi Rewari 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Department of Anaesthesiology All India Institute of Medical Sciences,Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9818304880  
Fax    
Email  vimirewari@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences,Ansari Nagar, New Delhi -110029 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesNew Delhi 
Address  Department of Anaesthesiology, All India Institute of Medical Sciences,Ansari Nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vimi Rewari  All India Institute of Medical Sciences,New Delhi  Room no. 5007,Department of Anaesthesiology,Academic block
South
DELHI 		 9818304880

vimirewari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,All India Institute of Medical Sciences,Ansari Nagar, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hypertensive patients undergoing surgery requiring orotracheal intubation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glidescope® Videolaryngoscope  Patients with hypertension controlled on antihypertensive medications scheduled for elective surgery under general anaesthesia requiring orotracheal intubation will be intubated using Glidescope® Videolaryngoscope.This will be used for and during intubation only. 
Comparator Agent  Macintosh direct laryngoscope  Patients with hypertension controlled on antihypertensive medications scheduled for elective surgery under general anaesthesia requiring orotracheal intubation will be intubated using Macintosh direct laryngoscope.This will be used for and during intubation only. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with hypertension controlled on antihypertensive medications scheduled for elective surgery under general anaesthesia requiring orotracheal intubation 
 
ExclusionCriteria 
Details  1.Age <18 yrs
2.History of coronary artery disease
3.History of difficult intubation
4.Difficult Airway
5.BMI>30
6.Cervicospinal disease
7.Otolaryngologic surgeries
8.Neurosurgery
9.Gastroesophageal reflux
10.Secondary hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of hemodynamic responses (Blood pressure and heart rate) to orotracheal intubation using the Macintosh direct laryngoscope and the Glidescope® videolaryngoscope.   1.Baseline
2.Post induction
3.Pre intubation
4.At the time of intubation
5.At 1,2,3,4,5 minutes following intubation
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total intubation time
2.Number of intubation attempts
3.Complications during intubation
4.Postoperative airway morbidity assessed after 24 hrs - sore throat, hoarseness, dysphagia, and cough
 		 1.After intubation
2.24 h after the surgery  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2014 
Date of Study Completion (India) 30/10/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The aim of the study is to compare the classic intubating device, the Macintosh direct laryngoscope with the Glidescope® videolaryngoscope for orotracheal intubation in hypertensive patients scheduled for surgery under general anaesthesia. The Primary outcome is to compare  hemodynamic responses (Blood pressure and heart rate) to orotracheal intubation using the Macintosh direct laryngoscope and the Glidescope® videolaryngoscope. The Secondary outcomes are  Total intubation time,   Number of intubation attempts, Complications during intubation and Postoperative airway morbidity assessed after 24 hrs - sore throat, hoarseness, dysphagia, and cough.

Fifty patients with hypertension controlled on antihypertensive medications scheduled for elective surgery under general anaesthesia requiring orotracheal intubation will be randomly divided into two groups of 25 each and assessed on the above mentioned outcomes.

 
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