| CTRI Number |
CTRI/2025/02/080804 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects and onset of action of two drugs in patients undergoing off pump coronary artery bypass graft surgery |
|
Scientific Title of Study
|
Comparison of intubating conditions and hemodynamic effects between Rocuronium and Cisatracurium in patients undergoing off pump coronary artery bypass graft surgery :A randomized double blinded study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSivalakshmi |
| Designation |
Resident |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Anesthesiology department,Sri Ramachandra Medical College, Room no -510,new girls pg hostel, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
8680838912 |
| Fax |
|
| Email |
rsivalakshmi11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAHESH VAKAMUDI |
| Designation |
Professor |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Anesthesiology department, Sri Ramachandra institute of higher education and research, porur, chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
Vakamudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSivalakshmi |
| Designation |
Post graduate |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Anesthesiology department,Sri Ramachandra Medical College, Room no -510,new girls hostel, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
8680838912 |
| Fax |
|
| Email |
rsivalakshmi11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and research hospital, porur, chennai ,600116 |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Sri Ramachandra University Porur, Chennai -600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSivalakshmi R |
Sri Ramachandra medical College and research hospital |
OR complex,A6 and D6 Anesthesiology Department,porur, Chennai -600116
Chennai
TAMIL NADU |
08680838912
rsivalakshmi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTEE |
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 |
Cisatracurium group |
Cisatracurium -0.15 mg /kg as a induction dose given as a bolus -intravenously (6 *ED 95) |
| Comparator Agent |
Rocuronium group |
Rocuronium -1 mg/kg as a induction dose given as a bolus -intravenously (3 *ED95 ) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist(ASA) status 3 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Inability to give consent to the study
Coagulopathy, sepsis, hepatic or renal failure
Allergic to Local Anaesthetic drugs
Pre existing neuromuscular disorder
Pregnant female
Ejection fraction less than 40%
ASA -4 and above |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of action
Hemodynamic effects of Heart rate after tracheal intubation between two groups |
Heart rate-baseline,at 1 minute,3 minute, 5 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Interpretation of TOF count for the onset of action |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Neuro muscular blockers are very important adjuvant to general anaesthesia. They aid in Endotracheal intubation, Mechanical ventilation, reduce anaesthetic requirements ,facilitate surgery for long hours and decrease oxygen consumption. An ideal neuromuscular blocking agent should have rapid onset of action ,produce good intubating condition rapidly ,intermediate to short duration of action ,provide rapid airway control. In the development of new neuro muscular blocking agents, the anaesthesiologist is now provided with drugs that are almost free of unwanted side effects, have a time course of action that allows great control of their activity and in most cases, allows the anaesthesiologist to substitute then for succinylcholine. In selecting a neuro muscular blocking agent, an anaesthetist stives to achieve three competing goals : 1. Rapid adequate muscle relaxation 2. Hemodynamic stability 3. Predictable complete return of skeletal muscle function In this study comparision between Rocuronium and Cisatracurium hemodynamic effects and rapid onset of action . |