| CTRI Number |
CTRI/2024/03/064891 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of lma supreme with classic using low dose of muscle relaxant |
|
Scientific Title of Study
|
Comparative evaluation of ease of insertion of laryngeal mask airway supreme with laryngeal mask airway classic using low dose atracurium during 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 Sumedha |
| Designation |
Junior resident |
| Affiliation |
GGSMCH FARIDKOT PUNJAB |
| Address |
Department of anaesthesiology, Guru Gobind Singh Medical College and hospital,faridkot,punjab
Faridkot
PUNJAB
151203
India |
| Phone |
7986462101 |
| Fax |
|
| Email |
sumedhasachdeva95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh kumar |
| Designation |
Associate Professor |
| Affiliation |
Guru gobind singh medical College and Hospital,Faridkot |
| Address |
Department of anaesthesia,Guru gobind singh medical College and Hospital,Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9464887097 |
| Fax |
|
| Email |
mukeshktala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh kumar |
| Designation |
Associate Professor |
| Affiliation |
GGSMCH Faridkot punjab |
| Address |
Department of anesthesia, Guru Gobind Singh Medical College and Hospital,faridkot,punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9464887097 |
| Fax |
|
| Email |
mukeshktala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia Guru Gobind Singh medical College and Hospital, faridkot punjab |
|
|
Primary Sponsor
|
| Name |
Guru Gobind singh medical College hospital |
| Address |
Department of anaesthesiology,Guru gobind singh medical College and Hospital, Faridkot punjab |
| 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 Sumedha |
Guru Gobind Singh Medical College and Hospital |
Department of anesthesiology,
GGSMCH Faridkot, punjab
Faridkot
PUNJAB |
7986462101
sumedhasachdeva95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee GGSMCH Farifkot |
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 |
Ease of insertion of Laryngeal Mask Airway classic |
Using low dose of atracurium in general anaesthesia in surgeries under 1hr |
| Comparator Agent |
Ease of insertion of LMA supreme |
Using low dose of low dose of atracurium in general anaesthesia in surgeries under 1hr |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I&II
Age 20-65yrs
Surgical procedures not exceeding 1hr |
|
| ExclusionCriteria |
| Details |
Any condition that increases the risk of GERD
Patient with respiratory tract disease
Morbid obesity
Previous history hypersensitivity to atracurium
Pregnancy |
|
|
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 compare the ease of insertion of LMA classic with LMA supreme using low dose of atracurium undergoing elective surgeries
To assess the ease of insertion of LMA supreme using low dose of atracurium undergoing elective surgery |
Outcome will be assessed after 1.5 yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of insertion of LMA classic with LMA supreme using low dose of atracurium in patients undergoing elective surgeries |
Outcome will be assessed at the end of surgery after 1.5 yrs |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
10/04/2024 |
| 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="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
|
LMA classic and supreme is a 1st and 2nd line generation LMA respectively. In this we will insert LMA using low dose of atracurium and compare the ease of insertion of both as atracurium a muscle relaxant will relax the muscle and get to know how much it helps in ease of insertion. |