| CTRI Number |
CTRI/2025/08/092835 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two airway devices i gel and i gel plus in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of i gel with i gel plus in patients undergoing elective surgeries under general anaesthesia.A prospective randomized double blinded study |
| 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 PREETHI R |
| Designation |
POSTGRADUATE STUDENT DEPARTMENT OF ANAESTHESIA |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA SDMCMSH MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA 580009
INDIA
Dharwad
KARNATAKA
580009
India |
| Phone |
7904767574 |
| Fax |
|
| Email |
preethi6796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMOHAMMED ANWAR HUSSAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
COLLEGE OF MEDICAL SCIENCE ANSDMD HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA SDMCMSH MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
INDIA
Dharwad
KARNATAKA
580009
India |
| Phone |
990289315 |
| Fax |
|
| Email |
dranwarh17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMOHAMMED ANWAR HUSSAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
COLLEGE OF MEDICAL SCIENCE ANSDMD HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA SDMCMSH MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
INDIA
Dharwad
KARNATAKA
580009
India |
| Phone |
990289315 |
| Fax |
|
| Email |
dranwarh17@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF MEDICAL SCIENCE |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL,MANJUSHREE NAGAR, SATTUR COLONY,DHARWAD, KARNATAKA -580009 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| PREETHI R |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA, 2ND FLOOR, SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL ,MANJUSHREE NAGAR SATTUR DHARWAD
Dharwad
KARNATAKA |
7904767574
preethi6796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM COLLEGE OF MEDICAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L024||Cutaneous abscess, furuncle and carbuncle of limb, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I gel |
Insertion of i gel supraglottic airway device in patients undergoing elective surgery under general anaesthesia |
| Intervention |
I gel plus |
Insertion of i gel plus supraglottic airway device in patients undergoing elective under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 2 3
In elective surgery under general anaesthesia expecting to last less than 60min |
|
| ExclusionCriteria |
| Details |
1 Patient refusal
2 Anticipated difficult Airway
3 Risk of aspiration
4 BMI more than 35 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the 1st attempt insertion success rate
of i-gel and i-gel Plus, defined as the provision of
effective management through the device from
insertion until the end of procedure. |
1min,2min,3min,4min,5min,15min,30min,60min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess ease and time of insertion. 2.To compare oropharyngeal leak pressure. 3.To evaluate incidence of complications
Intraoperative complications -
i)Airway trauma
ii)Dislodgement
iii) ventilation failure
IV) Laryngospasm
V) Bronchospasm. Postoperative complications
i) Sore throat
ii) Hoarseness of voice. |
1min,2min,3min,4min,5min,15min,30min,60min;24hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/08/2025 |
| 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 - NO
|
|
Brief Summary
|
- Study procedure - Ethical committee approval will be taken
- Informed consent will be obtained
- Preoperative evaluation will be done
- Randomly allocated on two groups which will be computer generated
- Standard general anaesthesia steps followed and intubated supine
- Appropriate size of i gel or i gel plus will be choosen
- randomly of size 3,4,5 depending on patient weight (30- 50kg,51-70kg,71-100kg) respectively.
- Successful placement of the i-gel Plus will be confirmed by
- adequate chest rise, presence of bilateral breath sounds on auscultation, and a capnographic waveform consistent with effective ventilation.
- PARAMETERS OBSERVED:
- 1. 1 st attempt insertion
- 2. Ease of insertion
- 3. Time taken for insertion
- 4. Any complications
|