| CTRI Number |
CTRI/2021/09/036426 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
TO COMPARE ATRACURIUM AND CISATRACURIUM IN PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
COMPARISON OF ATRACURIUM AND CISATRACURIUM WITH REGARDS TO THEIR POTENCY, ONSET TIME OF NEUROMUSCULAR BLOCKADE AND RECOVERY IN PATIENTS UNDERGOING 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 |
Dheeraj Gopal Ravindran |
| Designation |
Junior Resident |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
| Address |
Dept of Anesthesiology Dr. D. Y. Patil Medical College Hospital & Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9562372037 |
| Fax |
|
| Email |
93dheeraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHHAYA SURYAWANSHI |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
| Address |
Dept of Anesthesiology Dr. D. Y. Patil Medical College Hospital & Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dheeraj Gopal Ravindran |
| Designation |
Junior Resident |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
| Address |
Dept of Anesthesiology Dr. D. Y. Patil Medical College Hospital & Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9562372037 |
| Fax |
|
| Email |
93dheeraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil Medical College, Hospital & Research Centre, Sant Tukaram Nagar, Pimpri, Pune, 411018 |
|
|
Primary Sponsor
|
| Name |
Dheeraj Gopal Ravindran |
| Address |
Dept. of Anesthesiology, Dr. D. Y. Patil Medical College, Hospital & Research Centre, Sant Tukaram Nagar, Pimpri, Pune, 411018 |
| Type of Sponsor |
Other [other] |
|
|
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 |
| Dheeraj Gopal Ravindran |
Hightech OT complex, 5th floor, Hightech building |
Dr. D. Y. Patil Medical College, Hospital & Research Centre, Sant Tukaram Nagar, Pimpri, Pune, 411018
Pune
MAHARASHTRA |
9562372037
93dheeraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 & ASA 2 patients |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Atracurium |
Intravenous Atracurium 0.5mg/kg loading dose followed by 0.15mg/kg maintenance with regards to potency, onset time of neuromuscular blockade and recovery in patients undergoing surgeries under general anaesthesia |
| Comparator Agent |
Intravenous Cisatracurium |
Intravenous Cisatracurium 0.15mg/kg loading dose and 0.03mg/kg maintenance with regards to potency, onset time of neuromuscular blockade and recovery in patients undergoing surgeries under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I or II fit patients.
2. Patients aged between 18 and 60 years of age.
3. Patients undergoing surgeries under general anaesthesia.
4. Haemodynamically stable patients with all routine investigations within normal limits and without any comorbidities.
5. Written informed consent from the concerned patient. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in the study.
2. Patients with ASA grade III and above physical status.
3. Patients who are aged less than 18 and more than 60 years of age.
4. Patients who are posted for emergency procedures.
5. Patients with known allergy to the study drugs.
6. Patients with difficult intubation.
7. Patients who are obese.
8. Patients who have psychiatric, neurological, neuromuscular or cardiovascular disease or impairment of hepatic or renal function. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare onset time for intubation.
2. To observe intubating conditions.
3. To compare duration of neuromuscular blockade. |
Time taken from administration of study drug to intubation in seconds and the duration of neuromuscular blockade in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe hemodynamic effects of both drugs.
2. To observe any side effects. |
Hemodynamic parameters recorded before induction, after giving study drug, at the time of intubation and at 1, 2, 3, 5, 10 and 15 min after intubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/09/2021 |
| 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="0" |
|
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
|
It is a prospective, randomized, double blinded study of comparison of two non depolarizing neuromuscular blocking agents which are Inj. Atracurium and Inj. Cisatracurium in patients undergoing surgeries under general anaesthesia with regards to their potency, onset time of neuromuscular blockade and recovery. Intubating conditions, hemodynamic parameters and side effects if any will also be observed and recorded. |