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CTRI Number  CTRI/2025/11/097382 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 01/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Compare Ease of Ventilation Using a Facemask Before and After Giving Muscle Relaxant Medication 
Scientific Title of Study   Comparative Analysis of Facemask Ventilation Effectiveness Pre and Post Neuromuscular Blocking Drug Administration: 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  MEDHA DINESH RAI 
Designation  M Sc Anaesthesia and Operation Theatre Technology 
Affiliation  K S Hegde Medical Academy  
Address  5th floor Department of Anaesthesia and Operation Theatre Technology K S Hegde Medical Academy Nithyananda Nagar Deralakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8296495041  
Fax    
Email  medhashetty1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SHARADA ADIGA M 
Designation  Senior resident Department of Anaesthesiology and Critical Care 
Affiliation  Justice K S Hegde Charitable Hospital 
Address  Department of Anaesthesiology and Critical Care Justice K S Hegde Charitable Hospital

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740442123  
Fax    
Email  Sharada.3149@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHARADA ADIGA M 
Designation  Senior resident Department of Anaesthesiology and Critical Care 
Affiliation  Justice K S Hegde Charitable Hospital 
Address  Department of Anaesthesiology and Critical Care Justice K S Hegde Charitable Hospital

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740442123  
Fax    
Email  Sharada.3149@gmail.com  
 
Source of Monetary or Material Support  
Justice K S Hegde Charitable Hospital Deralakatte Mangalore 575018 Karnataka India 
 
Primary Sponsor  
Name  MEDHA DINESH RAI 
Address  Department of Anaesthesia and Operation Theatre Technology K S Hegde Medical Academy Nithyananda Nagar Deralakatte Mangaluru 575018 Karnataka India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sharada Adiga M  Justice K S Hegde Charitable Hospital  Department of Anaesthesiology and Critical Care medicine K S Hegde Medical Academy Nithyananda Nagar Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA 
9740442123

Sharada.3149@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K S HEGDE MEDICAL ACADEMY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (2) ICD-10 Condition: N645||Other signs and symptoms in breast, (3) ICD-10 Condition: H738||Other specified disorders of tympanic membrane,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing general anaesthesia
Adult patients of age greater than or equal to 18 years and less than or equal to 65 years
Patients with American Society of Anesthesiologists grade I and II
BMI between 18 to 30
Patients receiving vecuronium 
 
ExclusionCriteria 
Details  Planned awake tracheal intubation
Full stomach
A known allergy to the medications being studied
Pregnancy
Neuromuscular disorder
Rapid sequence intubation
Facial deformity
Anticipated difficult mask ventilation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Facemask ventilation before and after Neuromuscular blocking drug administration in terms of peak
airway pressure, expired tidal volume, minute ventilation, ETCO2 and SpO2.  
4 minutes in intraoperative  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the ease of Face mask ventilation and
Comfort of anaesthesiologist.  
4 minutes in intraoperative  
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/11/2025 
Date of Study Completion (India) 30/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The most fundamental and important skill in airway management is facemask ventilation, which is the primary line of treatment in patients who are apnoeic. It is an essential element of airway management skills crucial for both general anaesthesia and rescue oxygenation. During general anaesthesia, it is vital for ensuring adequate oxygenation and ventilation of the patient after the administration of anaesthetic / muscle relaxant agents. This technique involves placing a mask over the patient’s nose and mouth and applying positive pressure to facilitate the flow of oxygen or anaesthetic gases into the lungs. In emergency situations, facemask ventilation becomes an indispensable tool for providing immediate oxygenation to the patients who are unable to breathe independently. Mastery of this skill is essential for preventing complications such as hypoxia and ensuring effective airway management in a variety of clinical scenarios. The routine use of neuromuscular blocking drugs (NMBDs) before testing mask ventilation is a subject of debate. While NMBDs generally assist with intubation and may improve facemask ventilation, they can also obstruct ventilation by causing upper airway collapse. Advocates for "testing" the ability to ventilate before administering NMBDs argue that the risk of complete airway obstruction due to NMBD induced collapse could lead to a “cannot intubate, cannot ventilate” scenario if intubation attempts fail. On the other hand, some suggest that residual muscle tone after anaesthesia induction might create resistance during mask ventilation, which could be misinterpreted as difficult mask ventilation. DMV arises as a result of several technique-related and / or airway-related issues. . There is some evidence for administering an NMBD immediately after induction to facilitate ventilation, enabling early identification of patients at risk of difficult ventilation, facilitating prompt airway management, potentially reducing the risks associated with hypoxia. Therefore, the current study is envisaged to assess how neuromuscular blocking medication affects facemask ventilation in individuals undergoing general anaesthesia.
 
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