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CTRI Number  CTRI/2025/11/097668 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing three ways of placing a soft breathing device during anesthesia. 
Scientific Title of Study   Comparative evaluation of three different techniques (standard, reverse and rotation) of I-Gel insertion in patients undergoing surgery under General Anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sivagurunathan 
Designation  DNB Anaesthesia resident 
Affiliation  Swani Dayanand hospital 
Address  Department of Anaesthesia, Swami Dayanand Hospital, Dilshad Garden, Delhi – 110095, India
Dilshad Garden, Delhi – 110095, India
East
DELHI
110095
India 
Phone  919500724100  
Fax    
Email  awesomesivag@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonal Sharna 
Designation  Consultant 
Affiliation  Swani Dayanand hospital 
Address  Department of Anaesthesia, Swami Dayanand Hospital, Dilshad Garden, Delhi – 110095, India
Dilshad Garden, Delhi – 110095, India
East
DELHI
110095
India 
Phone  9650637028  
Fax    
Email  sonalsharma921@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sivagurunathan 
Designation  DNB Anaesthesia resident 
Affiliation  Swani Dayanand hospital 
Address  Department of Anaesthesia, Swami Dayanand Hospital, Dilshad Garden, Delhi – 110095, India
Dilshad Garden, Delhi – 110095, India
East
DELHI
110095
India 
Phone  919500724100  
Fax    
Email  awesomesivag@gmail.com  
 
Source of Monetary or Material Support  
Swami Dayanand Hospital, Dilshad Garden, East Delhi – 110095, India. 
 
Primary Sponsor  
Name  Swami Dayanand Hospital 
Address  Department of Anaesthesia, Swami Dayanand Hospital, Dilshad Garden, East Delhi – 110095, India. 
Type of Sponsor  Other [Hospital/Institute] 
 
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 Sivagurunathan  Swami Dayanand Hospital  Room No.18, Department of Anaesthesia, Swami Dayanand Hospital, Dilshad Garden, Delhi – 110095, India
East
DELHI 
9500724100

awesomesivag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HIEC SDNH - Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reverse  Igel insertion using reverse technique - the device is inserted with its concave surface facing the hard palate and then rotated 180 degrees upon reaching the oropharynx. 
Comparator Agent  Rotation  Igel insertion using rotational technique - It involves a 90-degree counterclockwise rotation during insertion to mitigate resistance from the tongue and facilitate smoother placement. 
Intervention  Standard  Igel insertion using standard technique - The conventional method where the the device is inserted along the hard palate in the neutral head position. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA Physical Status I and II
Mallampati Class I–II
BMI 18–25 kg/m²
Elective surgeries requiring general anaesthesia
Surgeries in supine position
 
 
ExclusionCriteria 
Details  Predicted difficult airway (Mallampati III/IV, restricted mouth opening, limited neck mobility)
Risk of aspiration (full stomach, GERD, pregnancy)
Upper respiratory tract infection or recent sore throat
Emergency surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the first-attempt success rate of i-GEL insertion using the standard, reverse, and rotational techniques.  At the time of insertion 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time taken for i-GEL insertion among the three techniques.
To compare the oropharyngeal leak pressure (OLP) achieved with each technique.
To compare the fiberoptic view of placement with each technique.
To compare the ease of placement of orogastric tube with each technique.
To compare the incidence of insertion-related complications, including blood staining, cough and sore throat at 1 hour and 24 hours.
 
At the time of insertion, during surgery and after surgery 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
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)   24/11/2025 
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="6"
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 randomised, controlled trial aims to compare the efficacy of the three techniques of iGel insertion in adult patients undergoing elective surgeries under general anaesthesia. A total of 264 ASA I–II patients will be randomly divided into three groups: standard technique (Group S), reverse technique involving a 180° rotation (Group R), and rotational technique using a 90° rotation (Group T). After standard anaesthetic induction and neuromuscular relaxation, the i-gel will be inserted using the assigned technique. Key outcome measures included first-attempt success rate, insertion time, oropharyngeal leak pressure, ease of gastric tube placement, fibreoptic grading, and the incidence of complications such as sore throat, blood staining, and dysphagia at 1 and 24 hours.

By providing a comprehensive head-to-head comparison of standard, reverse, and rotational i-gel insertion methods, this research intends to generate clinically relevant evidence that can enhance anaesthetic practice. The findings are expected to assist anaesthesiologists in selecting the most effective technique for i-gel placement, thereby improving patient safety and procedural efficiency in airway management.


 
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