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CTRI Number  CTRI/2024/08/072975 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 18/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare the effects on blood gas measurements and gastric volume in patients undergoing laparoscopic surgeries with or without ventilatory assistance using face mask during start of anaesthesia 
Scientific Title of Study   Effects on ABG parameters and gastric volume with or without facemask ventilation during induction in patients undergoing laparoscopic surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Veena Chatrath 
Designation  Professor and Head, Department of Anaesthesia, Government Medical College, Amritsar 
Affiliation  Government Medical College, Amritsar 
Address  Department of Anaesthesia, Government Medical College, Amritsar Amritsar PUNJAB 143001 India

Amritsar
PUNJAB
143001
India 
Phone  9814112355  
Fax    
Email  drveenachatrath@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Chatrath 
Designation  Professor and Head, Department of Anaesthesia, Government Medical College, Amritsar 
Affiliation  Government Medical College, Amritsar 
Address  Department of Anaesthesia, Government Medical College, Amritsar Amritsar PUNJAB 143001 India

Amritsar
PUNJAB
143001
India 
Phone  9814112355  
Fax    
Email  drveenachatrath@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena Chatrath 
Designation  Professor and Head, Department of Anaesthesia, Government Medical College, Amritsar 
Affiliation  Government Medical College, Amritsar 
Address  Department of Anaesthesia, Government Medical College, Amritsar Amritsar PUNJAB 143001 India

Amritsar
PUNJAB
143001
India 
Phone  9814112355  
Fax    
Email  drveenachatrath@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Government Medical College, Circular Road, Amritsar Punjab 143001 India 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Government Medical College, Amritsar 
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 Sanjeet Kaur  Government Medical College, Amritsar  Department of Anaesthesia Amritsar PUNJAB
Amritsar
PUNJAB 		 9877492902

sanjeetkaur127@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Medical College, Amritsar  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  Patients receiving oxygenation via facemask for 3 minutes and during apnoea period, not followed by positive pressure ventilation during apnoea period  We will insert arterial cannula under local anaesthesia for obtaining ABG samples. Then we will provide oxygenation via facemask for 3 minutes, which will be continued during apnoea period, but no positive pressure ventilation will be provided during apnoea period to 30 patients (Group NV). Effect on ABG parameters at various points of time and gastric volume using ultrasonography will be noted and compared with the other group. Total duration of intervention is from the start of anaesthesia to completion of surgery. 
Intervention  Patients receiving oxygenation via facemask for 3 minutes followed by positive pressure ventilation during apnoea period  We will insert arterial cannula under local anaesthesia for obtaining ABG samples. Then we will provide oxygenation via facemask for 3 minutes followed by positive pressure ventilation during apnoea period to 30 patients (Group V) during induction of anaesthesia. Effect on ABG parameters at various points of time and gastric volume using ultrasonography will be noted and compared with the other group. Total duration of intervention is from the start of anaesthesia to completion of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to ASA grade I and II
Patients undergoing elective laparoscopic surgeries under general anaesthesia
Adequate fasting that is 8 hours for solids and 2 hours for clear fluids
BMI less than 30 kg per m2 
 
ExclusionCriteria 
Details  Patient refusal
Pregnant or nursing mother
Diaphragmatic palsy
BMI more than or equal to 30 kg per m2
Patients with history of cardiac or respiratory disease
Patients with history of hepatic or renal disease
Patients allergic to drugs involved in the study
Patients on drugs which affect the gastrointestinal dynamics such as metoclopramide or domperidone or ondansetron or granisetron or atropine
Patients with gastroesophageal regurgitation
Patients with history of gastrointestinal surgery or trauma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of facemask oxygenation with or without positive pressure ventilation on gastric antral volumes measured by portable ultrasonography
To compare the effect of facemask oxygenation with or without positive pressure ventilation on ABG parameters like PaO2 and PaCO2 and pH and HCO3 values
Surgeon satisfaction score 		 Time from start of anaesthesia till completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the risk of gastric content regurgitation and aspiration in patients undergoing facemask oxygenation with positive pressure ventilation and patients receiving facemask oxygenation without positive pressure ventilation
To note any complication related to the procedure 		 Time from start of anaesthesia till completion of surgery 
 
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   Phase 2 
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="0"
Months="9"
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   This study is a prospective, randomized parallel group trial comparing the effect on ABG parameters and gastric volume using ultrasonography with or without facemask ventilation during induction of anaesthesia in patients undergoing laparoscopic surgeries. The study will be conducted in Government Medical College, Amritsar on 60 ASA grade I-II patients of either sex in the age group of 18 to 60 years scheduled for laparoscopic surgery under general anaesthesia, randomly divided into two groups of 30 patients each- Group ’V’ will receive oxygenation via facemask for 3 minutes followed by positive pressure ventilation during apnoea period and Group ’NV’ will receive oxygenation for 3 minutes via facemask and this oxygenation will be continued during apnoea period without positive pressure ventilation. The data thus obtained will be analyzed and compared statistically. 
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