| CTRI Number |
CTRI/2024/12/078219 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| 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 Sugammadex and Neostigmine for Reversing effect of Muscle Relaxant in Long Surgeries Under General Anesthesia |
|
Scientific Title of Study
|
COMPARISON OF REVERSIBILITY OF SUGAMMADEX AND NEOSTIGMINE TO VECURONIUM USED AS MUSCLE RELAXANT UNDER 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 |
Payodhi Modi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Eduacation and Research |
| Address |
Department of Anaesthesiology,
JawaharlalNehru MedicalCollege,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8269787777 |
| Fax |
|
| Email |
payodhimodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjot Ninave |
| Designation |
Professor |
| Affiliation |
Datta Megeh Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
JawaharlalNehru MedicalCollege,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8821213404 |
| Fax |
|
| Email |
drsusann02@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Payodhi Modi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
JawaharlalNehru MedicalCollege,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8269787777 |
| Fax |
|
| Email |
payodhimodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi , Wardha, Maharshtra (442001) |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College , Datta Meghe Institute of Higher Education and Research , Sawangi Meghe , Wardha , Maharashtra , 442001 |
| 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 |
| Dr Payodhi Modi |
AVBRH, Sawangi , Wardha, Maharshtra (442001) |
Department of Anaesthesia
Wardha
MAHARASHTRA |
8269787777
payodhimodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection neostigmine as reversal agent |
Injection neostigmine as reversal agent in patient after surgery, traditional reversal agent , dose dependent effect , half life of 15 to 30 min |
| Intervention |
injection sugammadex as a reversal agent |
Injection sugammadex as reversal agent in patient after surgery , newer drug , dose dependent action , half life 100 to 150 min . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
age 18 to 65 years
ASA grade 1
ASA grade 2
ASA grade 3
patient willing to participate in study
prolonged duration surgery under general anaesthesia more than 4 hours |
|
| ExclusionCriteria |
| Details |
lack of valid informed consent
ASA grade 4
patient with bleeding disorder
patient on medication known to interact with neuromuscular blocking drugs |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| recovery from general anaesthesia after administration of reversal |
Administration of reversal to 24 hours |
|
|
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="68"
Sample Size from India="68"
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)
|
01/01/2025 |
| 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.In contrast to neostigmine, sugammadex rapidly and effectively re- verses moderate and deep levels of vecuronium-in- duced neuromuscular blockade (NMB) , and is also effective for immediate reversal of blockade. We wanted to compare between reversibility of sugammadex and neostigmine in prolonged surgeries . Aim is to compare the efficacy of sugammadex with neostigmine for reversal of the effects of vecuronium as muscle relaxant. Objective is to compare the reversibility of neostigmine with sugammadex using TOF
To compare : 1. Time required for complete reversal . 2. Any residual paralysis / block with standard doses and requirement of added doses. 3. Side effect if any in post operative period (muscle pain , recurarization / apnea). This study includes patients classified Under American Society of Anaesthesiologists Physical status I,II&III planned for surgery under general anesthesia. Group A will receive neostigmine 0.05 mg/ kg . If TOF not till T4 then dose converted to 1 mg/ kg. Group B will receive sugammadex 2mg/ kg. If in deeper plain of anaesthesia then 4 mg/ kg. The onset, duration and side effects of post operative analgesia will be recorded and compared |