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CTRI Number  CTRI/2025/08/092464 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two devices i-gel Plus and i-gel in terms of their performance in patients undergoing laparoscopic cholecystectomy surgery. 
Scientific Title of Study   Comparative Evaluation Of Oropharyngeal Seal Pressure Of I-gel With I-gel Plus In Adult Patients Undergoing Laparoscopic Cholecystectomy Under General Anaesthesia: A Randomised 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  Sandhiya B 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College And Associated Lok Nayak Hospital 
Address  Room No 315 third floor Department of Anaesthesiology and intensive Care BL Taneja Block Maulana Azad Medical College India

Central
DELHI
110094
India 
Phone  9952426947  
Fax    
Email  sandhiyab44120@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia Wadhawan 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Room No 312 third floor Department of Anaesthesiology and intensive Care BL Taneja Block Maulana Azad Medical College

Central
DELHI
110094
India 
Phone  9818314062  
Fax    
Email  soniawadhawan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Sandhiya B 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no.315, Third foor, Department of Anaesthesiology,Maulana azad medical college, Bahadur shah jafar marg, new delhi

Central
DELHI
110094
India 
Phone  9952426947  
Fax    
Email  sandhiyab44120@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad medical college and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg New Delhi 
 
Primary Sponsor  
Name  Maulana Azad medical college and associated Lok Nayak Hospital 
Address  Maulana azad medical college, Bahadur shah jafar marg, new delhi -110002 
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 
DrSandhiya B  Lok Nayak Hospital  OT block , OT 1 new operation theatre block department of anaesthesiology
Central
DELHI 		 9952426947

sandhiyab44120@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  i-gel group  In this group, patient will be put i-gel ,oropharyngeal seal pressures will be measured five minutes after device insertion and five minutes after creating pneumoperitoneum.Gastric volume will be assessed before and after putting gastric tube and fibreoptic assessment of vocal cords will also be done.  
Intervention  i-gel Plus group  In this group, patient will be put i-gel Plus ,oropharyngeal seal pressures will be measured five minutes after device insertion and five minutes after creating pneumoperitoneum.Gastric volume will be assessed before and after putting gastric tube and fibreoptic assessment of vocal coreds will also be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA Grade 1,2,3 
 
ExclusionCriteria 
Details  1.Body Mass Index (BMI)Greater Than or equal to 35kg/m2
2.Pregnancy
3.Increased risk of aspiration (such as Gastroesophageal reflux disease, diabetes mellitus etc.)
4. Anticipated difficult airway 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the mean oropharyngeal seal pressures between i-gel and i-gel Plus five minutes after device insertion under general anaesthesia  It will be done after induction of general anesthesia- five minutes after device insertion. 
 
Secondary Outcome  
Outcome  TimePoints 
Mean oropharyngeal seal pressure five minutes after creating pneumoperitoneum  It will be done intraoperatively five minutes after creating pneumoperitoneum 
Time taken for successful device placement.  It will be measured in seconds while inserting the device 
Number of attempts for successful device placement  It will be done after induction of general anaesthesia 
Insertion ease of device  It will be subjective assessment done after induction of general anaesthesia 
First attempt success of gastric tube insertion  It will be done after device insertion 
Brimacombe scoring for assessment of device placement  It will be done after device insertion 
Complications if any with either device  It will be done during removal of the device  
 
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   Phase 4 
Date of First Enrollment (India)   20/08/2025 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Anyone

  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 [sandhiyab44120@gmail.com].

  6. For how long will this data be available start date provided 01-04-2028 and end date provided 01-04-0001?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Title of my thesis is, COMPARATIVE EVALUATION OF OROPHARYNGEAL SEAL PRESSURE OF I-GEL WITH I-GEL PLUS IN ADULT PATIENTSUNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA. We are going to take sample size of 72.36 in each group and we are going to compare sealing pressures of i-gel and i-gel Plus five minutes after device insertion and five minutes after creating pneumoperitoneum, Number of attempts taken for device insertion, insertion ease, first attempt success of gastric tube insertion and brimacombe scoring for successful device placement will also be done. 
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