| CTRI Number |
CTRI/2025/04/085822 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Evaluation Between Baska Mask AND I-gel Supraglottic Airway Devices In Patients Undergoing Surgery Under General Anaesthesia |
|
Scientific Title of Study
|
A Comparative Evaluation Between Baska Mask AND I-gel For Oropharyngeal Leak Pressure In Patients Undergoing Surgery Under General Anesthesia- A Prospective Randomized Controlled 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 |
Md Parwez Alam |
| Designation |
Junior Resident |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh |
| Address |
Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8267810012 |
| Fax |
|
| Email |
parwezalam996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Hussain Amir |
| Designation |
Professor |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY JAWAHARLAL NEHRU MEDICAL COLLEGE ALIGARH MUSLIM UNIVERSITY ALIGARH |
| Address |
Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
09897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Parwez Alam |
| Designation |
Junior Resident |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY JAWAHARLAL NEHRU MEDICAL COLLEGE ALIGARH MUSLIM UNIVERSITY ALIGARH |
| Address |
Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8267810012 |
| Fax |
|
| Email |
parwezalam996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 202002 India |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh |
| Address |
Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 202002 India |
| Type of Sponsor |
Government 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 |
| MD PARWEZ ALAM |
Jawaharlal Nehru Medical College, AMU |
Department Of Anaesthesiology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh-202002 India
Aligarh
UTTAR PRADESH |
08267810012
parwezalam996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(REGD) JAWAHARLAL NEHRU MEDICAL COLLEGE HOSPITAL FACULTY OF MEDICINE ALIGARH MUSLIM UNIVERSITY ALIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inserting BASKA mask device for General Anaesthesia |
Comparing BASKA mask with Igel for patient undergoing general anaesthesia for oropharyngeal leak pressure, ease of insertion, attempts to insert the device, overall success rate, position with fiberoptic laryngoscope, haemodynamic changes, and post insertion complication upto extubation of patient |
| Comparator Agent |
Inserting I gel for General Anaesthesia |
Comparing BASKA mask with Igel for patient undergoing general anaesthesia for oropharyngeal leak pressure, ease of insertion, attempts to insert the device, overall success rate, position with fiberoptic laryngoscope, haemodynamic changes, and post insertion complication upto extubation of patient |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Written and informed consent
2. Weight between 40-80 kg
3. ASA Grade 1 and 2 patients
4. All MP Grades
5. Patents planned for elective surgery requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Any pathology of oral cavity that may obstruct the insertion of device or mouth openings less than 2.5 cm
Expected duration of surgery longer than 2 hours
3. Potential full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia)
4. Lack of consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure |
Leak Pressure will be noted immediately following mask insertion and 10 min of surgery at which equilibrium will be reached |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of ease of insertion.
2.Comparison in attempts to insert the device.
3.Overall success rate.
4.Comparison of position with fiberoptic laryngoscope.
5.Comparison of hemodynamic changes.
6.Comparison of post-insertion complication. |
number of attempts(1 or 2), POGO score(100%,50%,0%), To measure changes in heart rate, mean arterial blood pressure and oxygen saturation( pre induction, post intubation, and and after 3 minutes and 5 minutes) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="0"
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
|
A Comparative Evaluation Between Baska Mask And I-gel For Oropharyngeal Leak Pressure In Patients Undergoing Surgery Under General Anaesthesia- A Prospective Randomized Controlled Study.
Having a proper airway is the most important factor in establishing normal respiration during surgery under general anaesthesia. Supraglottic Airway Devices(SAD) are claimed to produce no cardiopulmonary response during intubation, nor stimulate laryngeal reflexes, require fewer anaesthetic medications, and to have fewer complications and side effects such as coughing during awakening or sore throat.
Baska mask Isa new supraglottic noninflatable airway device that has a self sealing membranous cuff that inflates during inspiration and deflates during expiration. An inbuilt tab facilitates insertion of the device. It also has an oesophageal drainage inlet, a side channel to facilitate aspiration of gastric contents and an integral bite-block.
The I-gel is a supraglottic airway device with an anatomically designed non-inflatable mask that snugly fits onto the peri-laryngeal framework. The device has a buccal cavity stabiliser with an airway channel and a gastric tube insertion channel.
In our study, we aim to compare the efficacy of Baska mask with I-gel in terms of Oropharyngeal leak pressure, Intubation time, number of attempts for successful intubation, POGO score, ease of insertion of device, changes in Hear Rate, Blood Pressure following insertion and removal of device in patients undergoing surgery under general anaesthesia. |