| CTRI Number |
CTRI/2024/10/074726 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of clinical performance of igel and block buster LMA |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF CLINICAL PERFORMANCE OF I-GEL AND LMA- BLOCKBUSTER IN ADULT PATIENTS UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA
|
| 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 Neha Singh |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anesthesia ,
LLRM Medical College, Meerut
Uttar pradesh
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9807538320 |
| Fax |
|
| Email |
neha0895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Varun |
| Designation |
Associate professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anesthesia,
LLRM Medical College, Meerut
Uttar pradesh
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9568766156 |
| Fax |
|
| Email |
nickysangeeta78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta Varun |
| Designation |
Associate professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anesthesia,
LLRM Medical College, Meerut
Uttar pradesh
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9568766156 |
| Fax |
|
| Email |
nickysangeeta78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia LLRM Medical College meerut uttar pradesh 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical College |
| Address |
Department of Anesthesia, LLRM medical college, meerut, uttar pradesh 250004 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 |
| Dr Neha Singh |
LLRM Medical College |
Department of Anesthesia , LLRM Medical College,Meerut, Uttar pradesh
Meerut
UTTAR PRADESH |
9807538320
neha0895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee office of principal LLRM medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade1&2 undergoing elective surgery under general anaesthesia |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Block buster LMA |
Block buster LMA has some unique feature like 95 degree in angulated airway that makes ventilation and intubation easier and it also has a gastric port for the suction.
We compare various parameters 1,3, 5 minutes after placement and then every 15 minutes till end of surgery. |
| Comparator Agent |
I-GEL |
I-GEL is a second generation SGAD with anatomically designed, non inflatable mask made up of soft thermoplastic elastomer and a separate gastric channel also present.
We compare Parameters 1,3,5 minute after placement and then every 15 minutes till end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Anticipated normal airway in preanaesthetic evaluation
2. Age 18-65 years of either sex
3. Adult patients undergoing elective surgeries under general anaesthesia
4. BMI 18-24
5. Hemodynamically stable patients |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway
2. Anticipated high risk of aspiration ( hiatus hernia, Full stomach, GERD, Pregnancy
3. Bleeding and Coagulation disorders
4. Patients with any severe systemic disease
5. Patients undergoing emergency surgery
6. History of Obstructive sleep apnea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To see the ease of insertion
2. Assessment of hemodynamic changes (HR, SBP, DBP, Spo2)
3. Oropharyngeal leak pressure |
Baseline hemodynamics changes every 1,3,5 ,15 minutes and then every 15 minutes till end of surgery
Oropharyngeal leak pressure after correct placement (around 10 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Trauma to airway during insertion
2. Postoperative sore throat
3. Any other complication during procedure |
After 1 hours of post extubation and then every 6 hours till 24 hours of surgery |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="2"
Months="0"
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
|
A comparative study between efficiency of I-GEL and Block buster LMA in adults patients undergoing elective surgery. We conducted this study for 2 years . We compared changes in hemodynamic parameters , oropharyngeal airway seal and other complications. This study conducted in healthy patients with minimum comorbidities. |