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CTRI Number  CTRI/2024/02/062633 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 13/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy of different airway devices which are used for giving general anaesthesia during laparoscopic gynaecological surgeries.  
Scientific Title of Study   Efficacy of I gel®, Baska Mask and Blockbuster® LMA for the airway management in laparoscopic gynaecological surgeries: A Randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti 
Designation  Post Graduate Resident 
Affiliation  AIIMS PATNA 
Address  Room No 13 Department of Anaesthesiology Ground Floor AIIMS PATNA OPD complex Patna BIHAR 801507 India

Patna
BIHAR
801507
India 
Phone  8335016897  
Fax    
Email  preetirajwar17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhyuday Kumar 
Designation  Associate Professor 
Affiliation  AIIMS PATNA 
Address  Room no 506 Department of Anaesthesiology B Block OT Complex AIIMS PATNA Patna BIHAR 801507 India

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Preeti 
Designation  Post Graduate Resident 
Affiliation  AIIMS PATNA 
Address  Room No 13 Department of Anaesthesiology Ground Floor AIIMS PATNA OPD Complex Patna BIHAR 801507 India

Patna
BIHAR
801507
India 
Phone  8335016897  
Fax    
Email  preetirajwar17@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Patna 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  Department of Anaesthesiology B Block OT Complex, AIIMS Patna, Phulwarisharif, Patna, Bihar, 801507 
Type of Sponsor  Research institution and hospital 
 
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 Preeti  All India Institute of Medical Sciences, Patna  Operating Room No:5 and 10, B Block, OT Complex, Department of Anaesthesiology, IPD Building, AIIMS Patna
Patna
BIHAR 		 8335016897

preetirajwar17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Patna  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  Baska Mask  Size 3,4,5 Route: Airway management Duration: Intraoperative period 
Intervention  Blockbuster®  Size 3,4,5 Route: Airway management Duration: Intraoperative period 
Comparator Agent  I-gel®  Size 3,4,5 Route: Airway management Duration: Intraoperative period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. ASA physical status I & II
2. BMI: 18 to 30 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Anticipated difficult airway
3. History of gastroesophageal reflux diseases
4. Patients with previous abdominal surgery or comorbidities that would affect surgical time, time under anaesthesia, intragastric pressure and abdominal pressure.
5. Expected duration of surgery more than 3 hours.
6. Any surgery with expected postoperative ICU admission
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure  T1: After successful insertion of the SAD
T2: 15 minutes after pneumoperitonium and Trendelenburg position
T3: 1 hour after pneumoperitonium and Trendelenburg position 
 
Secondary Outcome  
Outcome  TimePoints 
Peak pressure
Insertion attempt
Insertion time
Airway manipulation
Perioperative and postoperative anaesthesia related problems
 		 (peak pressure, insertion attempts, insertion time, airway manipulations) are to be assessed after securing supraglottic devices.
Perioperative anaesthesia related problems are to be assessed intraoperatively.
Postoperative anaesthesia related problems are to be assessed after surgery in the post anaesthesia care unit 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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 4 
Date of First Enrollment (India)   29/02/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preetirajwar17@gmail.com].

  6. For how long will this data be available start date provided 23-10-2025 and end date provided 23-10-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
This study is a randomized controlled trial regarding the comparison of oropharyngeal leak pressure between the I-Gel®, Blockbuster®, and Baska Mask supraglottic airway devices in laparoscopic gynaecological surgeries.The laparoscopic gynaecological surgeries often presents unique challenges during general anaesthesia due to trendelenburg position and pneumoperitoneum  .Oropharyngeal leak pressure (OLP) is an essential indicator of airway seal and is directly correlated with successful ventilation during laparoscopic gynaecological surgeries . Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in laroscopic gynaecological surgeries.
Research hypothesis is we hypothesise that Baska Mask and Blockbuster SAD will have a higher OLP as compared to I gel in patients undergoing laparoscopic gynaecological surgery.
The primary objective is to compare the oropharyngeal leak pressure between I-gel®, Blockbuster®, and Baska Mask during laparoscopic gynaecological surgeries, and the secondary objective is to evaluate and compare: The peak pressure before and after pneumoperitoneum, Insertion attempt, Insertion time, Number and type of airway manipulation required, Perioperative and postoperative anaesthesia related problems.
The inclusion criteria include patients between 18 to 60 years of age, ASA physical status I–II, BMI 18 to 30, and the exclusion criteria include Patient refusal, Anticipated difficult airway, History of gastroesophageal reflux diseases, Patients with previous abdominal surgery and/or comorbidities that would affect surgical time, time under anaesthesia, intragastric pressure and abdominal pressure., Expected duration of surgery > 3 hours, Any surgery with expected postoperative ICU admission.
The sample size was calculated based on the study by Jeon WJ et al. a sample size of 99 patients (33 each group) will be taken, considering dropouts and errors in the sample size calculation.

 
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