| CTRI Number |
CTRI/2019/06/019575 [Registered on: 07/06/2019] Trial Registered Prospectively |
| Last Modified On: |
05/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cisatracurium vs Rocuronium: to compare the INTUBATING conditions following these two drugs |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMISED DOUBLE BLINDED STUDY TO ASSESS THE INTUBATING CONDITIONS OF TWO NON DEPOLARISING MUSCLE RELAXANTS CISATRACURIUM AND ROCURONIUM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajasundari Baskaran |
| Designation |
Postgraduate in Anesthesia |
| Affiliation |
Sri Ramachandra university |
| Address |
no 28/56 thanthai Periyar Nagar , first street , Ayanavaram Chennai
Department of Anaesthesiology , Sri Ramachandra university, no 1 , Sri Ramachandra nagar , porur, Chennai -600116
Chennai
TAMIL NADU
600023
India |
| Phone |
9791170876 |
| Fax |
|
| Email |
Drsundu77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Mahesh Vakamudi |
| Designation |
Dean of faculty |
| Affiliation |
Sri Ramachandra university |
| Address |
Department of Anaesthesiology , Sri Ramachandra university, no 1 , Sri Ramachandra nagar , porur, Chennai .
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
Vakamudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Mahesh Vakamudi |
| Designation |
Dean of faculty |
| Affiliation |
Sri Ramachandra university |
| Address |
Department of Anaesthesiology , Sri Ramachandra university, no 1 , Sri Ramachandra nagar , porur, Chennai .
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
Vakamudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra University, No 1 , Sri Ramachandra nagar , porur, Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Sri ramachandra university |
| Address |
No 1, sri Ramachandra nagar , porur , Chennai |
| 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 |
| Rajasundari |
Sri Ramachandra University |
Department of anaesthesiology ,Sri Ramachandra university, no 1 , Sri Ramachandra nagar , porur, Chennai
Chennai
TAMIL NADU |
9791170876
Drsundu77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra University |
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 |
0.1 mg/ kg of Inj.Cisatracurium |
This group of patients will receive 0.1 mg / kg of Inj.cisatracurium and the intubating conditions are monitored for 30 minutes from the injection of drug . |
| Comparator Agent |
0.6 mg/ kg of Inj.rocuronium |
This group of patients will receive 0.6 mg / kg of Inj.rocuronium and the intubating conditions are monitored for 30 minutes of the injection of drug. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Surgeries under general anaesthesia with tracheal intubation following non depolarising muscle relaxants
ASA class1
ASA class 2
Elective surgery |
|
| ExclusionCriteria |
| Details |
ASA class 3 and above
Chronic liver disease
Chronic kidney disease
Age>75 years
Obesity > 30 kilograms per metre square
Patients with anticipated difficult airway
Patients with diseases affecting neuromuscular transmission ( myopathies) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage depression of adductor pollicis twitch at 180 seconds |
Percentage depression of adductor pollicis twitch at 180 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Copenhagen consensus conference score
Heart rate
Mean arterial pressure
Rare side effects |
Preinduction, immediately post induction and after 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/06/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title : A Prospective Randomised Double Binded Study To Compare The Intubating Conditions Of Two Non Depolarising Muscle Relaxants Cisatracurium And Rocuronium Aim : To compare the percentage depression of adductor pollicis twitch at 180 seconds following single dose of these two nondepolarising muscle relaxants and alps other parameters like heart rate , mean arterial pressure, Copenhagen consensus conference score and rare side effects. Methodology: After obtaining institutional ethics committee approval , patients who are fit under the inclusion criteria will be entrolled in the study and randomised into two groups. Group A will receive 0.1 mg/ Kg of Inj.Cisatracurium and Group B will receive 0.6 mg / kg of Inj.Rocuronium . The study parameters will be monitored. Statistical analysis will be done . |