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CTRI Number  CTRI/2023/01/049352 [Registered on: 31/01/2023] Trial Registered Prospectively
Last Modified On: 15/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   STUDY THE EFFECT OF MUSCLE RELAXANT ON FACEMASK VENTILATION 
Scientific Title of Study   STUDY THE EFFECT OF NEUROMUSCULAR BLOCKADE ON FACEMASK VENTILATION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  HARISH KUMAR 
Designation  RESIDENT IN ANAESTHESIA 
Affiliation  RESIDENT IN ANAESTHESIA, DEPARTMENT OF ANAESTHESIA, M.S RAMAIAH MEDICAL COLLEGE , BANGALORE 
Address  DEPARTMENT OF ANAESTHESIA, 2ND FLOOR, NEXT TO MULTIDISCIPLINARY ICU, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR, BANGALORE NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
DEPARTMENT OF ANAESTHESIA, 2ND FLOOR, NEXT TO MULTIDISCIPLINARY ICU, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR, BANGALORE NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
Bangalore
KARNATAKA
560054
India 
Phone  7986066575  
Fax    
Email  hkj09.hk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR LEENA H PARATE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ASSOCIATE PROFESSOR , MS RAMAIAH MEDICAL COLLEGE, BANGALORE 
Address  DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR LEENA H PARATE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ASSOCIATE PROFESSOR , MS RAMAIAH MEDICAL COLLEGE, BANGALORE 
Address  DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR, MS RAMAIAH MEDICAL COLLEGE HOSPITAL, NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE
SAME AS ABOVE
Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIA MS RAMAIAH MEDICAL COLLEGE , NEW BEL ROAD BANGALORE - 560054 
 
Primary Sponsor  
Name  MS RAMAIH MEDICAL COLLEGE 
Address  NEW BEL ROAD, MSRIT POST, MSR NAGAR BANGALORE - 560054 
Type of Sponsor  Private 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 LEENA H PARATE  MS RAMAIAH MEDICAL COLLEGE HOSPITAL  DEPARTMENT OF ANAESTHESIA,, 2ND FLOOR, NEXT TO MULTIDISCIPLINARY ICU, NEW BEL ROAD, MSRIT POST, BBANGALOR
Bangalore
KARNATAKA 		 09480525925

dr_leenag@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE MS RAMAIAH MEDICAL COLLEGE HOSPITAL  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 
Intervention  CHECKING TIDAL VOLUME AFTER GIVING INJ ATRACURIUM 40mg IV  COMPARING TIDAL VOLUME BEFORE AND AFTER GIVING INJ ATRACURIUM 40mg IV 
Comparator Agent  CHECKING TIDAL VOLUME BEFORE GIVING TIDAL VOLUME  COMPARING TIDAL VOLUME BEFORE AND AFTER GIVING NEUROMUSCULAR BLOCKADE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  PATIENT SCHEDULED TO UNDERGO ELECTIVE SURGERY 
 
ExclusionCriteria 
Details  PATIENT REFUSAL
ANTICIPATED DIFFICULT AIRWAY
OBESE PATIENT
INCREASED RISK OF PULMONARY ASPIRATION ( GASTRO-OESOPHAGEAL REFLUX , FULL STOMACH AND INTESTINAL OBSTRUCTION)
ALLERGIC TO STUDY DRUG
PREGNANCY
NEUROMUSCULAR DISORDERS
HEPATIC AND RENAL INSUFFICIENCY
PATIENT REQUIRING ORAL AIRWAY FOR EFFECTIVE MECHANICAL VENTILATION 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MEASURING TIDAL VOLUME (12 BREATHS)BEFORE AND AFTER ADMINISTRATION OF NEUROMUSCULAR BLOCKING AGENT DURING FACEMASK VENTILATION  BEFORE GIVING MUSCLE RELAXANT AND THREE MINUTES AFTER GIVING MUSCLE RELAXANT 
 
Secondary Outcome  
Outcome  TimePoints 
COMPARING AUDIBLE MASK LEAKAGE AND GASTRIC INSUFFLATION BEFORE AND AFTER NEUROMUSCULAR BLOCKADE  BEFORE NEUROMUSCULAR BLOCKADE AND AFTER NEUROMUSCULAR BLOCKADE 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   31/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Facemask ventilation is the most fundamental and important skill for safe airway management during induction of anaesthesia. Upper airway obstruction encountered during ventilation may occur at the oropharynx, soft palate or epiglottis which can be overcome with the triple airway manoeuvre - head tilt, chin lift and jaw thrust ( advancing the mandible forward so the lower teeth are in front of the upper teeth). Even in difficult tracheal intubation, facemask ventilation is an alternative step to ensure sufficient oxygenation until the patient’s airway is secured. Some of the studies conclude that the neuromuscular blocking agent facilitates tracheal intubation and might improve facemask ventilation. and other studies says neuromuscular blockade neither improve nor hindered mask ventilation in patient with normal airway. Difficult mask ventilation secondary to laryngospasm and opioid-induced muscle rigidity can be improved following administration of neuromuscular blocking agent, making mask ventilation easier. Even a minute increase in tidal volume is potentially clinically significant in hypoxic patient. Study of this topic has an important implication for the question of whether neuromuscular blockade should be administered following adequate mask ventilation or not. Therefore, the main aim of study is to assess the impact of neuromuscular block on facemask ventilation in term of tidal volume. The primary outcome is the tidal volume measuring before and after neuromuscular blockade. Secondary outcome will be comparing audible mask leakage and gastric insufflation before and after neuromuscular blockade. 
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