| CTRI Number |
CTRI/2023/03/050162 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing two doses of Pregabalin for prevention of fasciculations and myalgia caused by Succinylcholine |
|
Scientific Title of Study
|
Comparison of two doses of Pregabalin for preventing Succinylcholine-induced fasciculations and myalgia in patients undergoing surgery under General Anaesthesia: A Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malavika Sasidharan |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College, Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College, Bangaramma Sajjan Campus,Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7034085160 |
| Fax |
|
| Email |
malavikas040@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renuka Holyachi |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Medical College, Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College,Bangaramma Sajjan Campus,Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9886492178 |
| Fax |
|
| Email |
renuka312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malavika Sasidharan |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College, Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College, Bangaramma Sajjan Campus,Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7034085160 |
| Fax |
|
| Email |
malavikas040@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 |
| Malavika Sasidharan |
Shri B M Patil Medical College |
Department of Anaesthesiology, Bangaramma Sajjan Campus,BLDE University,Vijayapura,
Bijapur
KARNATAKA |
7034085160
malavikas040@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 |
Capsule PREGABALIN |
A drug used for Neuropathic pain,fibromyalgia,convulsions,etc,
Route:Oral Capsule,
Dosage:either 75mg or 150mg,
Frequency:Single dose 2 hours prior to surgery |
| Comparator Agent |
Saccharin pill |
Sucrose sugar sweetner pills used as placebo,
Route:Oral Tablet,
Dosage:49.2mg,
Frequency:single dose 2 hours prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgery under General Anaesthesia.
ASA grade 1 or 2
|
|
| ExclusionCriteria |
| Details |
Patients with drug allergies
Seizure history
Cardiac diseases
Impaired kidney or Liver function
Raised intracranial pressure or intraocular pressure
Patients on Antiepileptics,antidepressants,calcium channel blockers
Pregnant and Lactating Females
|
|
|
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 |
| To compare the efficacy of two doses of Pregabalin in preventing Succinylcholine-Induced fasciculations and myalgia |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic stability and 24 hour post operative analgesic requirement of the patients who received Pregabalin and the patients who received only Placebo |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="201"
Sample Size from India="201"
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)
|
05/03/2023 |
| 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
|
NIL |
|
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 Randomized,Parallel group,double blinded study.This study consists of 3 groups where Group A who will receive Capsule Pregabalin 75mg,Group B will receive Capsule Pregabalin 150mg and Group C will receive Saccharin pill as Placebo.201 patients posted for surgery under General Anaesthesia will be equally divided into these three groups as 67 each.The study will be conducted in Shri B M Patil Medical College,Vijayapura,Karnataka.The primary outcome is to compare the efficacy of two doses of Pregabalin in preventing Succinylcholine induced fasciculations and myalgia in patients undergoing surgery under General Anaesthesia.The secondary outcome is to compare the hemodynamic stability and 24 hour post operative analgesic requirement of the patients who received Pregabalin and the patients who received only Placebo. |