| CTRI Number |
CTRI/2025/05/086221 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Airway Devices for Safer Anesthesia in Keyhole Gallbladder Surgery. |
|
Scientific Title of Study
|
Comparison of clinical performance of LMA BlockBuster and Ambu AuraGain Supraglottic Airways in Laparoscopic Cholecystectomy: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aspari Mahammad Azeez |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences,Guwahati |
| Address |
2052, Department of Anaesthesiology, Critical Care and Pain Medicine,2nd floor, OPD building, AIIMS Guwahati, Silbharal, Changsari, Kamrup, Assam.
Kamrup
ASSAM
781101
India |
| Phone |
8427693477 |
| Fax |
|
| Email |
aspariazeez@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aspari Mahammad Azeez |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences,Guwahati |
| Address |
2052, Department of Anaesthesiology, Critical Care and Pain Medicine,2nd floor, OPD building, AIIMS Guwahati, Silbharal, Changsari, Kamrup, Assam.
Kamrup
ASSAM
781101
India |
| Phone |
8427693477 |
| Fax |
|
| Email |
aspariazeez@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aspari Mahammad Azeez |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences,Guwahati |
| Address |
2052, Department of Anaesthesiology, Critical Care and Pain Medicine,2nd floor, OPD building, AIIMS Guwahati, Silbharal, Changsari, Kamrup, Assam.
Kamrup
ASSAM
781101
India |
| Phone |
8427693477 |
| Fax |
|
| Email |
aspariazeez@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Critical Care and Pain Medicine,2nd floor, OPD building, AIIMS Guwahati, Silbharal, Changsari, Kamrup, Assam.Pin code 781101 |
|
|
Primary Sponsor
|
| Name |
AIIMS Guwahati |
| Address |
All India Institute of medical Sciences Guwahati Silbharal Changsari, Guwahati, Assam 781101 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aspari Mahammad Azeez |
AIIMS Guwahati |
Operation theatre complex,2nd floor, IPD building, Department of Anaesthesiology, Critical Care and Pain Medicine, AIIMS, Guwahati.781101.
Kamrup
ASSAM |
8427693477
aspariazeez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambu AuraGain (Group A) |
Ambu AuraGain Supraglottic airway insertion after anaesthesia induction |
| Comparator Agent |
Blockbuster (Group B) |
Blockbuster Supra Glottic Airway (SGA) insertion after anaesthesia induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status I-II
2. Scheduled for elective laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
1. BMI more than 35 kg/m²
2. Severe gastroesophageal reflux disease
3. Pregnancy
4. History of upper respiratory tract pathology/surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak pressure. |
N1-0,5,15 MIN
N2-0,5,15,30,45,60,75,90 MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insertion success rate on the first attempt |
At SGA insertion time |
| Insertion time |
at SGA insertion |
| Device insertion attempts |
at SGA Insertion |
| Fiberoptic grade of laryngeal alignment |
at SGA Insertion time |
| Hemodynamic changes: HR and MAP |
at baseline , immediately after SGA insertion |
| Ventilation parameters (Peak airway pressure, leak fraction) |
at 1 min After SGA insertion (T1),5 min Before Carboperitoneum (T2),5 min After Carboperitoneum (T3),5 min Before Removal of Carboperitoneum (T4),5 min After Removal of Carboperitoneum (T5) |
Incidence of postoperative complications
1. Post-operative sore throat (POST)
2. Hoarseness,
3.Cough
4.Laryngospasm,
5.Blood in SGA on removal
|
first 24 of post operative period |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/06/2025 |
| 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="11"
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 randomized controlled trial compares the clinical performance of LMA BlockBuster® and Ambu® AuraGain™ in patients undergoing laparoscopic cholecystectomy. The primary outcome is oropharyngeal leak pressure (OLP), with secondary outcomes including insertion success, time, fiber-optic view, and postoperative complications. The hypothesis is that BlockBuster® provides a better laryngeal seal and alignment. 160 patients were randomized under standardized general anesthesia. |