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CTRI Number  CTRI/2025/05/087672 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomized controlled trial to compare the blood pressure in response to placement of a tube in the trachea using a video laryngoscope or a video stylet in adults receiving general anesthesia  
Scientific Title of Study   A randomized controlled trial to compare the hemodynamic response to orotracheal intubation with c-mac video laryngoscope versus c-mac video stylet in adults receiving general anesthesia for elective surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Agrawal 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anesthesia, Room no 509, New Academic block, Lady Hardinge Medical college

Central
DELHI
110001
India 
Phone  8826640501  
Fax  -  
Email  garima2396@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Garima Agrawal 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anesthesia, Room no 509, New Academic block, Lady Hardinge Medical college Shahid bhagad singh marg,

Central
DELHI
110001
India 
Phone  8826640501  
Fax  -  
Email  garima2396@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Garima Agrawal 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anesthesia, Room no 509, New Academic block, Lady Hardinge Medical college Shahid bhagad singh marg

Central
DELHI
110001
India 
Phone  8826640501  
Fax  -  
Email  garima2396@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Lady Hardinge Medical College, shahid Bhagat Singh Marg, central Delhi 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College  
Address  Lady Hardinge Medical College New Delhi 110001  
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 Garima Agrawal  Lady Hardinge Medical College and associated hospitals  Department of Anaesthesia, Lady Hardinge Medical College
Central
DELHI 
08826640501

garima2396@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lady Hardinge Medical College and associated hospitals New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  C-mac video laryngoscope  either of the two devices are used for laryngoscopy and intubation to secure the airway and hemodynamic response to orotracheal intubation will be compared in ASA grade 1 adult patients receiving general anaesthesia for elective surgery. 
Intervention  C-mac video laryngoscope vs C-mac video stylet used for orotracheal intubation in adult patients receiving general anaesthesia for elective surgery  To compare the hemodynamic response (SBP, HR, DBP, MAP) to orotracheal intubation using the two devices in ASA grade 1 adult patients receiving general anaesthesia for elective surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA physical status 1
2. Elective surgery 
 
ExclusionCriteria 
Details  1. Anticipated difficult airway
2. Upper respiratory tract infection
3. Patients with high risk for aspiration such as hiatal hernia, gut surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic response (Systolic blood pressure ) orotracheal intubation using C-MAC video laryngoscope and C-MAC video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery  At preinduction and 1 minute after tracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to the changes in SBP, HR, DBP, MAP  At following time intervals
1. Preinduction
2. Preintubation
3. Immediately after tracheal intubation
4. At 1 minute after tracheal intubation
5. At 3 minutes after tracheal intubation
6. At 5 minutes after tracheal intubation 
To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to time taken for tracheal intubation defined as the time from introduction of laryngoscope to the time of first capnography trace.
 
time taken for tracheal intubation defined as the time from introduction of laryngoscope to the time of first capnography trace.
 
To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to number of failed intubation   Failure of intubation shall be defined if more than two attempts are taken to secure the
airway. In such a situation, the airway will be secured as per the anesthesiologist discretion
and the patient will be excluded from the study. 
To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to number of patients requiring Optimal External Laryngeal Manipulation for achieving successful intubation in each group  OELM shall be allowed for achieving successful intubation & number of patients
requiring application of this maneuver will be recorded.  
To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to number of patients with Orodental trauma  Tracheal Intubation 
 
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)   02/07/2025 
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)  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  

Laryngoscopy and intubation stimulate the sympathetic nervous system causing an increase in heart rate, blood pressure, pulmonary capillary wedge pressure and intracranial pressure. This hemodynamic response is transient, and is well tolerated by healthy individuals but can have deleterious consequences in high-risk patients such as those with hypertension, coronary artery diseases, intracranial space occupying lesion etc. Video laryngoscopy is now becoming a preferred method of tracheal intubation with its improved visualization and widespread availability. However, previous literature has shown that hemodynamic response to video laryngoscopy is similar to that of direct laryngoscopy as both the devices involve introduction of blades into the laryngopharynx exerting pressure to the base of the tongue, lodgment in the vallecula and elevation of the epiglottis.

C-MAC Video stylet with a deflectable tip has been recently introduced to facilitate orotracheal intubation in adults. It is an optical stylet that allows indirect view of laryngopharyngeal structures without exerting pressure on the adjoining tissues. However, introduction of the stylet into the oral cavity requires application of jaw thrust or manual lifting of the mandible by hooking the lower jaw to create a pharyngeal space in order to facilitate visualization of glottis. These maneuvers are also known to elicit a sympathetic response, however, there is no research comparing the hemodynamic response of video laryngoscopy versus video stylet intubation which involves manual displacement of the jaw.

There is paucity of literature comparing the hemodynamic response to orotracheal intubation by C-MAC video laryngoscope versus C-MAC video stylet in adult patients receiving general anaesthesia for elective surgery.

Our study will help us identify if  there is any difference in the hemodynamic response to orotracheal intubation using C-MAC video laryngoscope compared to C-MAC video stylet in adult patients receiving general anaesthesia for elective surgery and thus select appropriate laryngoscope for intubation in high risk patients.

 
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