| CTRI Number |
CTRI/2023/03/050858 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
19/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
For inserting LMA which is better rocuronium or succinyl choline |
|
Scientific Title of Study
|
Administration of low dose Rocuronium and low dose Succinylcholine for ease of insertion of LMA - A Prospective comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi T |
| Designation |
Junior Rsident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology
Shri B M Patil Medical College
BLDE University
Bangaramma Sajjan Campus
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9900582161 |
| Fax |
|
| Email |
swathikandgal19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidya Patil |
| Designation |
Professor and HOD |
| Affiliation |
Shri BM Patil Medical College |
| Address |
Department of Anaesthesiology
Shri B M Patil Medical College
BLDE University
Bangaramma Sajjan Campus
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
vidyapatila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi T |
| Designation |
Junior Rsident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology
Shri B M Patil Medical College
BLDE University
Bangaramma Sajjan Campus
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
990055 |
| Fax |
|
| Email |
swathikandgal19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College,Bangaramma Sajjan Campus,BLDE University,Vijayapura,Karnataka,Pin 586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College |
| Address |
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Karnataka
Pin 586103 |
| Type of Sponsor |
Private 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 |
| Swathi T |
Shri B M Patil Medical College |
Department of anaesthesiology, 3rd floor, Room No 01,
Bangaramma Sajjan Campus
Bijapur
KARNATAKA |
9900582161
swathikandgal19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri B M Patil Medical College |
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 |
Insertion of LMA |
The LMA is introduced behind the tongue with backward pressure using the index finger, pressing the device against the hard palate until it is completely inserted. |
| Comparator Agent |
Rocuronium |
All patients will be pre oxygenated and then induced with propofol, then 0.1 mg/ kg Rocuronium will be injected |
| Comparator Agent |
succinyl choline |
All patients will be pre oxygenated and then induced with propofol, then 0.1 mg/ kg succinyl choline will be injected. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 20-60 years.
2.Patients of either sex.
3.Patients admitted for elective surgeries under General Anesthesia with ASA Grade I & II
|
|
| ExclusionCriteria |
| Details |
1.Patients with full stomach, pregnant patient
2.Patients posted for emergency surgery
3.Patients with oral, perioral pathology such as tumors, abscess, or grossly enlarged tonsils
4.Patients with fixed reduced pulmonary compliance such as pulmonary fibrosis, severe cardiovascular, hepatic, or renal disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gagging, coughing, patient movement, Laryngospasm, Jaw relaxation , overall insertion ease |
At the time of insertion of LMA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts, Time taken for the insertion of LMA, Airway Trauma, blood pressure, pulse rate, oxygen saturation |
Interval of 1 ,5, 15 ,30 , 45 minutes |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
20/03/2023 |
| 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="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective comparative study. This study consists of 3 groups where Group A receives only propofol . Group B receives Propofol with Rocuronium (0.1 mg /kg ) and Group C receives Propofol with Succinyl choline. 111 patients posted for surgery under General Anesthesia will be equally divided in to three groups of 37 each. The study will be conducted in Shri B M Patil Medical College , Vijayapura , Karnataka. The primary outcome is to compare gagging, coughing, patient movement, laryngospasm, jaw relaxation while inserting LMA. The secondary outcome is to compare number of attempts , time taken for insertion, airway trauma following insertion of LMA. |