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CTRI Number  CTRI/2026/03/106694 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 22/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of i-gel and LMA Blockbuster airway devices in adults undergoing elective key hole surgeries to assess effectiveness in preventing air leakage. 
Scientific Title of Study   COMPARISON BETWEEN IGEL AND LMA BLOCKBUSTER FOR OROPHARYNGEAL LEAK PRESSURE IN ADULT PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES - ONE YEAR HOSPITAL BASED RANDOMISED CONTROL 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  Dr Shreya Lisa Thomas 
Designation  Junior Resident Anaesthesiology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9619692170  
Fax    
Email  drshreyalisathomas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chaitanya A Kamat 
Designation  MD DA Professor Anaesthesiology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  8150038305  
Fax    
Email  drchaitanya12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chaitanya A Kamat 
Designation  MD DA Professor Anaesthesiology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  8150038305  
Fax    
Email  drchaitanya12@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Shreya Lisa Thomas 
Address  Department of Anaesthesiology, JNMC,KLE, Nehru Nagar, Belagavi, KA-590010 
Type of Sponsor  Other [Self] 
 
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 Shreya Lisa Thomas  KLES Dr Prabhakar Kore Hospital and Medical Research Centre  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Nehru Nagar campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 		 9619692170

drshreyalisathomas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  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  I-gel Supraglottic airway  The I-gel supraglottic airway, which is a commonly used airway device is composed of a thermoplastic elastomer, features a non-inflatable cuff, integrated bite block, buccal cavity stabiliser, and gastric port. Its design conforms closely to the hypopharyngeal anatomy, facilitating rapid insertion and enabling adult-sized endotracheal tube passage. The oropharyngeal leak pressure will be checked 5 minutes after intubation and 5 minutes after pneumoperitoneum. The device will be inserted immediately after relaxation and present during the entire procedure. 
Intervention  Laryngeal Mask Airway Blockbuster  The LMA Blockbuster, a newer generation airway device, is made of soft silicone and has a unique 95° airway tube angulation that aligns with the oropharyngeal curve. Its design directs the endotracheal tube toward the glottic opening at a 30° angle, improving blind intubation success. The oropharyngeal leak pressure will be checked 5 minutes after intubation and 5 minutes after pneumoperitoneum. The device will be inserted immediately after relaxation and present during the entire procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Adults undergoing laparoscopic surgeries under general anaesthesia
Surgeries under 120 mins
Low risk patients
 
 
ExclusionCriteria 
Details  Difficult airway
High rish patients  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the leak in both devices at different pressures in laparoscopic surgeries.   5 minutes after induction and 5 minutes after pneumo-peritoneum is achieved.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare Ease of insertion & Insertion time of I-gel vs LMA Blockbuster  At the time of insertion of airway device during induction. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   06/04/2026 
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   This study is to compare a newer generation airway device with another commonly used airway device during general anaesthesia in laparoscopic surgeries. Here the leak in both airways are compared at different pressures. The lesser leak pressure would prove the device to be more effective. Half the sample size will receive the newer generation device and other half will receive igel. This study will also compare the ease in inserting airway tubes through the device. 
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