| CTRI Number |
CTRI/2023/04/051945 [Registered on: 25/04/2023] Trial Registered Prospectively |
| Last Modified On: |
23/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the cost and safety of Cisatracurium and Atracurium in patients undergoing Surgery |
|
Scientific Title of Study
|
Cost Analysis and Safety comparison between cisatracurium and atracurium in patients undergoing general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kumar TV |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma sajjan campus, Vijayapura
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma sajjan campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9444251481 |
| Fax |
|
| Email |
tvarunkumar2305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaykumar TK |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma sajjan campus, Vijayapura
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma sajjan campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
drvijay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumar TV |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma sajjan campus, Vijayapura
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma sajjan campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9444251481 |
| Fax |
|
| Email |
tvarunkumar2305@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 |
| Arun kumar TV |
Shri B M Patil Medical College |
Department of Anaesthesiology, Bangaramma Sajjan Campus, BLDE University, Vijayapura, Karnataka
Bijapur
KARNATAKA |
9444251481
tvarunkumar2305@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 |
Injection Atracurium
Route: Intravenous
Dosage: 0.5mg/kg
Frequency: during induction and maintainence of anaesthesia for surgeries within 2 hours |
Non Depolarising neuromuscular blocking agent for muscle relaxation |
| Intervention |
Injection Cisatracurium
Route: Intravenous
Dosage: 0.15mg/kg
Frequency: during induction and maintainence of anaesthesia for surgeries within 2 hours |
Non Depolarising Neuromuscular blocking agent for muscle relaxation. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age less than 70 years
ASA I and ASA II
Surgery less than 2 hours |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to drugs to be used
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the cost analysis and safety of cisatracurium and atracurium |
2 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/05/2023 |
| 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 ia a prospective , randomized comparative study. This study consists of 2 groups where Group A who wil receive Injection Atracurium 0.5mg/kg intravenously and Group B who wil receive Injection Cisatracurium 0.15mg/kg intravenously for patients posted for surgery under general anaesthesia less than 2 hours wil be equally divided into this 2 groups as 70 each. The study wil be conducted in Shri B M Patil Medical College, Vijayapura, Karnataka. The primary outcome is to compare the cost analysis and safety of cisatracurium and atracurium. |