| CTRI Number |
CTRI/2025/12/098276 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study on two devices used to give breaths for general anesthesia in Keyhole abdominal surgeries. |
|
Scientific Title of Study
|
A comparative study on use of Baska mask® vs i-gel® for general anesthesia in laparoscopic abdominal surgeries. |
| 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 V A Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V A Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajin Arul David |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8072252136 |
| Fax |
|
| Email |
ajinarul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi, Salem, Tamil Nadu, India - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi, Salem, Tamil Nadu, India - 636308 |
| 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 |
| Dr Ajin Arul David |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Department of Anaesthesiology, Room number 14
Salem
TAMIL NADU |
08072252136
ajinarul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Airway secured for general anesthesia in laparoscopic abdominal surgeries using Baska mask® supraglottic airway device. |
Patient airway is secured with appropriate sized Baska mask® supraglottic airway device once at the time of induction of general anesthesia.
Duration: Until successful placement and fixation of the device (approximately 1–2 minutes). |
| Comparator Agent |
Airway secured for general anesthesia in laparoscopic abdominal surgeries using i-gel® supraglottic airway device. |
Patient airway is secured with appropriate sized i-gel® supraglottic airway device once at the time of induction of general anesthesia.
Duration: Until successful placement and fixation of the device (approximately 1–2 minutes). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing laparoscopic abdominal surgeries under general anesthesia
2. Age group: 18 to 60 years
3. American Society of Anesthesiologists Physical Status (ASA-PS) I, II
4. Both male and female patients
5. Patient providing written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient refusal or inability to provide informed consent
2. Age less than 18 or more than 60 years
3. American Society of Anesthesiologists Physical Status (ASA-PS) III or higher
4. Pediatric patients
5. Obstetric patients
6. Restricted mouth opening of less than 2.5cm
7. Patients at increased risk of aspiration of gastric contents (GERD, esophageal strictures, achalasia cardia, inadequate period of NPO etc.) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare first-time successful insertion rate and the ease of insertion. |
First-time successful insertion rate and the ease of insertion are assessed and recorded immediately (0 minutes). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare successful insertion time, leak fraction and the post operative laryngopharyngeal complications. |
Successful insertion time, leak fraction recorded immediately after device insertion(0 minutes)
Post operative laryngopharyngeal complications recorded immediately after removing device, 2 hours, 12 hours post operatively. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/12/2025 |
| 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
|
This is a prospective, randomized clinical
study designed to compare two supraglottic airway devices—the Baska Mask® and
the i-gel®—for airway management during elective laparoscopic abdominal
surgeries under general anesthesia. Seventy adult patients (ASA physical status
I–II) will be randomly allocated into two equal groups of 35 each: Group BM: Airway secured with Baska Mask® Group IG: Airway secured with i-gel® All patients will receive standardized
anesthetic induction and maintenance, and airway insertion will be performed
after muscle relaxation. The number of insertion attempts will be limited to
three, with tracheal intubation performed if insertion fails. The primary objective is to compare the
first-time successful insertion rate and ease of insertion between the two
devices. Secondary objectives include comparing
insertion time, leak fraction, and postoperative laryngopharyngeal
complications such as sore throat, dysphagia, cough, or mucosal trauma at 0, 2,
and 12 hours postoperatively. The study aims to determine which device
offers easier and more effective airway management with fewer postoperative
complications in patients undergoing laparoscopic abdominal surgery.
|