| 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
|
|
|
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
|
|
|
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.
|