| CTRI Number |
CTRI/2025/08/093785 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Sugammadex in reversing muscle relaxation from Rocuronium and Vecuronium during operations |
|
Scientific Title of Study
|
Efficacy of Sugammadex in reversal of Rocuronium versus Vecuronium induced Neuromuscular Blockade - a randomized controlled double blind trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunnam Lakshmi Prathyusha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology, Kalinga Institute Of Medical Sciences, KIIT Deemed to be University, Bhubaneswar, Kordha
Khordha
ORISSA
751024
India |
| Phone |
9573782325 |
| Fax |
|
| Email |
gprathyusha39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritesh Roy |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology, Kalinga Institute Of Medical Sciences, KIIT Deemed to be University, Bhubaneswar, Kordha
Khordha
ORISSA
751024
India |
| Phone |
7008016886 |
| Fax |
|
| Email |
drriteshroy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayesha Pattnaik |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology, Kalinga Institute Of Medical Sciences, KIIT Deemed to be University, Bhubaneswar, Kordha
Khordha
ORISSA
751024
India |
| Phone |
9439616053 |
| Fax |
|
| Email |
ayesha.pattnaik@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Gunnam Lakshmi Prathyusha |
| Address |
Department Of Anaesthesiology, KIIT Deemed to be University, Bhubaneswar, Kordha |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gunnam Lakshmi Prathyusha |
Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, 751024
Khordha
ORISSA |
9573782325
gprathyusha39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute Of Medical Sciences |
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 |
Sugammadex in reversal of Rocuronium induced Neuromuscular Blockade |
Group 1 - 2mg/kg of Sugammadex will be administered for reversal of Rocuronium induced neuromuscular blockade.
|
| Comparator Agent |
Sugammadex in reversal of Vecuronium induced Neuromuscular Blockade |
Group 2- 2mg/kg of Sugammadex will be administered for reversal of Vecuronium induced neuromuscular blockade |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for Elective Surgery under General Anaesthesia.
American Society of Anaesthesiologists (ASA) physical status I and II.
|
|
| ExclusionCriteria |
| Details |
Neuromuscular disorder.
Suspected renal insufficiency.
Significant hepatic dysfunction.
Allergy to one of the drugs used in this study.
Pregnant and breast-feeding.
Surgery more than 2 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the time (in minutes) needed to achieve a TOF ratio of greater than 0.9 after administration of sugammadex.
|
To assess the time (in minutes) needed to achieve a TOF ratio of greater than 0.9 after administration of sugammadex.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Hemodynamic Parameters (SBP, DBP, MAP, HR, SP02) at 2, 5, 10, 15, 30, 60, 120 minutes.
Incidence of adverse effects like Hypotension, Bradycardia, PONV.
|
2, 5, 10, 15, 30, 60, 120 minutes.
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized study aims to evaluate the efficacy of sugammadex in reversing neuromuscular block induced by rocuronium versus vecuronium in adult patients undergoing elective surgery under general anesthesia. Neuromuscular blockade is routinely achieved using steroidal agents such as rocuronium and vecuronium, and reversal is traditionally done with neostigmine, which carries risks of incomplete recovery and adverse effects. Sugammadex, a novel gamma cyclodextrin, offers rapid and predictable reversal by encapsulating these agents, with a higher binding affinity for rocuronium. Patients will be randomized into two groups Group R which is rocuronium with sugammadex and Group V which is vecuronium with sugammadex. The primary outcome is time to recovery of train-of-four ratio greater than 0.9. Secondary outcomes include hemodynamic stability and adverse effects. The results may guide anesthesiologists in optimizing the choice of neuromuscular blocking agent when sugammadex is planned for reversal. |