| CTRI Number |
CTRI/2025/03/081617 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| 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
|
How Sugammadex Works: Comparing Its Effectiveness in Reversing Muscle Relaxants with Separate Doses vs. Continuous Drips of Vecuronium During Surgery |
|
Scientific Title of Study
|
Comparison of reversibility of Sugammadex between intermittent top-up and continuous infusion of Vecuronium in general anaesthesia. |
| 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 SNEHAl KABRA |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,
Jawaharlal Nehru Medical College,
Datta Meghe Institute of Higher Education and research
Datta Meghe ,
Sawangi (Meghe) ,
Wardha
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9130053121 |
| Fax |
|
| Email |
snehalkabra1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SANJOT NINAVE |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,
Jawaharlal Nehru Medical College,
Datta Meghe Institute of Higher Education and research
Datta Meghe ,
Sawangi (Meghe) ,
Wardha
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9921213404 |
| Fax |
|
| Email |
drsusann02@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SNEHAL KABRA |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,
Jawaharlal Nehru Medical College,
Datta Meghe Institute of Higher Education and research
Datta Meghe ,
Sawangi (Meghe) ,
Wardha
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9172818191 |
| Fax |
|
| Email |
drsnehalkabra1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinobha Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research, Meghe, Sawangi, Wardha, Maharashtra, India - 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi (Meghe) , Wardha - 442001
Maharashtra, India |
| 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 |
| Dr SNEHAL KABRA |
Acharya Vinobha Bhave Rural Hospital |
Department of Anaestheisa ,
Jawaharlal Nehru Medical College , Datta Meghe Institute of Higher Education and Research , Sawangi (Meghe) ,Wardha 442001, Maharashtra
Wardha
MAHARASHTRA |
9130053121
snehalkabra1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sugammadex with Vecuronium infusion |
Reversibility from general anaesthesia with vecuronium infusion after administration of 2mg/kg Sugammadex |
| Intervention |
Sugammadex with Vecuronium Top-up |
Reversibility from general anaesthesia with Vecuronium top-up after administration of 2mg/kg Sugammadex intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years to 70 years
ASA grade I/II/III
Patient willing to participate in the study
Surgery under general anaesthesia
Duration 3 to 5 hours |
|
| ExclusionCriteria |
| Details |
Lack of valif informed written consent
ASA grade IV
Patients on medication known to interact with neuromuscular blocking drugs, eg.Antibiotics (aminoglycosides, tetracycline), antidepressants, anticonvulsants, antiarrhythmics (calcium channel blockers and quinidine) and magnesium sulphate and patients with known allergy to sugammadex. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reversibility from general anaesthesia when TOF 4 appears after administration of sugammadex in intermittent top-up and continuous infusion of vecuronium. |
From time of administration of sugammadex to 30 min after administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required for complete reversal using TOF. |
Base line - time at which reversal drug was given.
end time - time at which TOF ratio of 0.9 is achieved. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included yes).
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Sugammadex is a modified γ-cyclodextrin designed to reverse the effects of the steroidal neuromuscular blocking agents (NMBAs) rocuronium and vecuronium by encapsulation with no effect on cholinergic transmission. Sugammadex rapidly and effectively re-verses moderate and deep levels of vecuronium-induced neuromuscular blockade (NMB) , and is also effective for immediate reversal of blockade. Lowest recommended dose is 2mg/kg. We wanted to compare its reversibility effect in vecuronium infusion and intermittent topup.AIM : To compare reversibility of sugammadex between intermittent top-up and continuous infusion of vecuronium in general anaesthesia . OBJECTIVES PRIMARY OBJECTIVE : To compare reversibility of sugammadex between intermittent top-up and continuous infusion of vecuronium in general anaesthesia . SECONDARY OBJECTIVES : To compareTime required for complete reversal using TOF. Any residual paralysis / block with sugammadex 2mg and requirement of added doses. Side effect if any , in post operative period (muscle pain , apnea) METHODOLOGY : This study includes patients classified under American Society of Anaesthesiologists. Physical status I, II& III planned for surgery under general anesthesia will receive 2mg/kg Sugammadex Group T will receive Intermittent top-up doses of Vecuronium.
Group CI will receive Continuous infusion of Vecuronium. |