| CTRI Number |
CTRI/2025/09/094321 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Trial to Study the Efficacy and Safety of airway devices I-gel Plus ® and LMA BlockBuster ™ in Elective Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
A Randomized Trial to Study the Efficacy and Safety of I-gel Plus ® and LMA BlockBuster ™ in Elective Laparoscopic Cholecystectomy |
| 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 Neeraj N N |
| Designation |
Junior Residant |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Aneasethesiology , AIIMS Gorakhpur Uttar Pradesh India 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8073967960 |
| Fax |
|
| Email |
neerajthampu@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHUPENDRA SINGH |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Aneasethesiology , AIIMS Gorakhpur Uttar Pradesh India 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9694744962 |
| Fax |
|
| Email |
abhiraj997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj N N |
| Designation |
Junior Residant |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Aneasethesiology , AIIMS Gorakhpur Uttar Pradesh India 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8073967960 |
| Fax |
|
| Email |
neerajthampu@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Neeraj N N |
| Address |
Department of Aneasthesiology AIIMS Gorakhpur contact no 8073967960email id neerajthampu@yahoo.in |
| Type of Sponsor |
Other [Self] |
|
|
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 Neeraj N N |
AIIMS GORAKHPUR |
f
medical sciences
Gorakhpur
Department of
Anaesthesiology,AIIMS
Gorakhpur Uttar
Pradesh India 273008
Gorakhpur
UTTAR PRADESH
Gorakhpur
UTTAR PRADESH |
8073967960
neerajthampu@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
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 |
| Comparator Agent |
Group B LMA BlockBuster ™ Airway device. |
Group B: Patients airway will be secured with the LMA BlockBuster ™,device. |
| Intervention |
Group I I-gel Plus ® Airway device |
Group I Patients airway will be secured with the I-gel Plus ®device. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2 patients posted for elective laparoscopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
Pt with anticipated difficult airway or BMI more than 35. GERD or full stomach. Suspected upper airway pathology and pregnancy |
|
|
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 oropharyngeal leak pressure (OLP) between I-gel Plus ®and LMA BlockBuster ™ |
intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess ease of insertion via comparing the insertion time and number of attempts taken
|
intraoperative |
To compare leak fraction
|
intraoperative |
To evaluate hemodynamic changes during insertion.
|
intraoperative |
To record and compare postoperative complications such as sore throat, hoarseness, dysphagia, mucosal trauma, and nausea/vomiting.
|
postoperative |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/09/2025 |
| 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 Yet Recruiting |
| 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 at AIIMS Gorakhpur compares the efficacy and safety of i-gel Plus® and LMA BlockBuster™ in adult patients undergoing elective laparoscopic cholecystectomy. Eighty patients were randomly assigned to two groups (n=40 each). The primary outcome was oropharyngeal leak pressure (OLP). Secondary outcomes included insertion time, number of attempts, hemodynamic changes, and postoperative complications. The study aims to guide the selection of an optimal supraglottic airway device for laparoscopic surgeries requiring effective airway sealing. |