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CTRI Number  CTRI/2024/08/072918 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study showing comparison of change in heart rate and blood pressure during use of two different types of laryngoscopes named as McCoy and CMAC in adult patients with normal blood pressure.  
Scientific Title of Study   Comparison of haemodynamic response to orotracheal intubation with McCoy verses CMAC laryngoscope in adult normotensive patients: A prospective observational study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitesh Manohar Parab  
Designation  Junior Resident Doctor 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Room number 10, New RMO hostel, near Sion hospital, Sion west , Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7208406207  
Fax    
Email  parabnitesh747@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anila D Malde 
Designation  Head of the Department of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Room number N424, 4th Floor, Department of anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion west

Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anila D Malde 
Designation  Head of the Department of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Room number N424, 4th Floor, Department of anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion west

Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and General Hospital, Sion west Mumbai  
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Lokmanya Tilak Municipal Medical College and General Hospital, Sion West, Mumbai 400022 
Type of Sponsor  Government medical college 
 
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 
Dr Nitesh Parab   Lokmanya Tilak Municipal Medical College and General Hospital  N424,Department of Anaesthesiology Lokmanya Tilak Municipal Medical College and General Hospital, Sion Mumbai 400022
Mumbai
MAHARASHTRA 		 7208406207

parabnitesh747@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either sex.
2. Patients of age group from 18 years to 70 years.
3. Patients belonging to American Society of Anesthesiologists (ASA) 
Grade I, II posted for surgery under GETA. 
 
ExclusionCriteria 
Details  1. ASA grade III, IV patients
2. Pregnant patients 
3. Patient’s refusal to participate in study.
4. Patients with known hypertension
5. Patients with past history of Cardiac disease or cerebrovascular disease
6. Patients with obesity
7. Patients with difficult airway 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the haemodynamic response (Pulse, SBP, DBP, MAP) to
laryngoscopy and endotracheal intubation using McCoy laryngoscope
and CMAC videolaryngoscope in normotensive patients undergoing
general endotracheal anesthesia. 		 To compare the haemodynamic response (Pulse, SBP, DBP, MAP) to 
laryngoscopy and endotracheal intubation using McCoy laryngoscope
and CMAC videolaryngoscope at baseline, 5 mins after injection fentanyl 2mcg/kg, 3.5mins after administration inj vecuronium, immediately after laryngoscopy, at 1min, 3 min ,5min, 10min, 15min and 20min after intubation  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare Cormack Lehane score.
2. To compare time required for intubation using both these laryngoscopes. 		 at baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   We propose to observe and compare haemodynamic response in
surgeries under general endotracheal anesthesia (GETA) using McCoy
laryngoscope and CMAC videolaryngoscope.Patients posted for elective surgery under GETA where McCoy or CMAC videolaryngoscope is used will be included in the study. Haemodynamic parameters (Pulse, Blood pressure,  SpO2, , ECG changes) will be studied during and after the intubation. Absolute difference between the values of vital parameters at different intervals from baseline will be calculated and then percentage change compared to baseline value will be calculated. This percentage change between the two groups will be analyzed using Unpaired T test. 
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