| CTRI Number |
CTRI/2019/03/018144 [Registered on: 18/03/2019] Trial Registered Prospectively |
| Last Modified On: |
14/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare two drugs cisatracurium and atracurium for general anaesthesia. |
|
Scientific Title of Study
|
A study on comparison of cisatracurium and atracurium for neuromuscular blockade and recovery characteristics in patients undergoing various elective surgeries under 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 |
Dr Ravi sharma |
| Designation |
Postgraduate student |
| Affiliation |
Jawahar lal nehru medical college, ajmer, rajasthan |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9413419324 |
| Fax |
|
| Email |
ravisplash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita jain |
| Designation |
Senior professor and guide |
| Affiliation |
Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita jain |
| Designation |
Senior professor and guide |
| Affiliation |
Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jln Medical College ajmer |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer |
| 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 Ravi sharma |
Jln Medical College ajmer |
Department of anaesthesiology jln medical college
Ajmer
RAJASTHAN |
9413419324
ravisplash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN 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 |
Neuromuscular monitoring in general anaesthesia |
For onset time and duration of neuromuscular blockade |
| Comparator Agent |
To compare cisatracurium and atracurium |
To compare neuromuscular blockade and recovery characteristics of 2 drugs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with ASA physical status I and II
2) Aged between 18 and 60 years
3) Patients with easy intubation (Mallampati grade I and II) |
|
| ExclusionCriteria |
| Details |
1) ASA physical status III and above
2) Age < 18 years or > 60 years
3) Predicted difficult intubation ( pregnant and obese patients ) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Duration of neuromuscular blockade |
1. Duration of neuromuscular blockade |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Onset time of neuromuscular blockade
2. Hemodynamic changes
3. Recovery profile ( Mean 25% recovery, Mean time of recovery )
4. Complications/ Adverse effects if any |
Duration of the study is around one year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2019 |
| Date of Study Completion (India) |
14/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To asses and compare the neuromuscular blockade and recovery characteristics of cisatracurium versus atracurium in adult patients undergoing various elective surgeries under general anaesthesia with respect to: Primary objectives 1. Duration of neuromuscular blockade Secondary objectives 1. Onset time of neuromuscular blockade 2. Hemodynamic changes 3. Recovery profile ( Mean 25% recovery, Mean time of recovery ) 4. Complications/ Adverse effects if any |