| CTRI Number |
CTRI/2025/03/081577 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
RANDOMIZED |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effectiveness of two medications for reversing
muscle paralysis caused by Vecuronium |
|
Scientific Title of Study
|
A comparative efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for the reversal of Vecuronium induced Neuromuscular blockade: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DR MELCHISEDEC SINGH |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE , CHRISTIAN MEDICAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE , CHRISTIAN MEDICAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB
Ludhiana
PUNJAB
141008
India |
| Phone |
9876620747 |
| Fax |
|
| Email |
msedec@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHEBA RATNA KUMARI KODALI |
| Designation |
PG RESIDENT |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
JUNIOR DOCTORS HOSTEL, 2ND FLOOR 2002, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, BROWN ROAD, LUDHIANA, PUNJAB
JUNIOR DOCTORS HOSTEL, 2ND FLOOR 2002, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, BROWN ROAD, LUDHIANA, PUNJAB
Ludhiana
PUNJAB
141008
India |
| Phone |
7823856537 |
| Fax |
|
| Email |
kodali.ksheeba22@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEBA RATNA KUMARI KODALI |
| Designation |
PG RESIDENT |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
JUNIOR DOCTORS HOSTEL, 2ND FLOOR 2002, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, BROWN ROAD, LUDHIANA, PUNJAB
JUNIOR DOCTORS HOSTEL, 2ND FLOOR 2002, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, BROWN ROAD, LUDHIANA, PUNJAB
PUNJAB
141008
India |
| Phone |
7823856537 |
| Fax |
|
| Email |
kodali.ksheeba22@yahoo.com |
|
|
Source of Monetary or Material Support
|
| CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
CHRISTIAN MEDICAL COLLEGE A ND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE , CHRISTIAN MEDICAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB |
| 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 SHEBA RATNA KUMARI KODALI |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE , CHRISTIAN MEDICAL COLLEGE, BROWN ROAD, LUDHIANA, PUNJAB
Ludhiana
PUNJAB |
7823856537
kodali.ksheeba22@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A comparative efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for the reversal of Vecuronium induced Neuromuscular blockade: A randomized controlled trial. |
Group A- Patients under General Anaesthesia with Neuromuscular blockade Inj Vecuronium will be reversed with Inj Sugammadex
|
| Comparator Agent |
A comparative efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for the reversal of Vecuronium induced Neuromuscular blockade: A randomized controlled trial. |
Group B- Patients under General Anaesthesia with Neuromuscular blockade Inj Vecuronium will be reversed with Inj Glycopyrrolate and Inj Neostigmine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA (American Society of Anaesthesiologists) I and II
2.All men and women.
3.Adult 18-60 years.
4.Elective General surgeries, Orthopedic, Laproscopic, Gynecological surgeries under general anaesthesia lasting for 2-3 hours.
5.Planned use of neuromuscular blocking drugs.
6.Planned endotracheal intubation and extubation in operating room. |
|
| ExclusionCriteria |
| Details |
1.Anticipation of difficult airway.
2.Known or suspected neuromuscular disorder impairing neuromuscular function.
3.Allergy to muscle relaxants.
4.A personal or family history of malignant hyperthermia.
5.Pregnant females, breast feeding mothers, or females in childbearing age using
contraceptives.
6.Renal impaired patients. |
|
|
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 |
| 1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide to time of recovery of TOF ratio to 0.9. |
Under minimal block, time taken for extubation is recorded at intervals of 5 mins, 10mins,15mins and so on. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post reversal physiological characteristics- Blood pressure, Heart rate, Spo2, Respiratory rate. |
At the interval of 0mins, 10mins, 20mins, 30mins, 60mins, 120mins |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
25/03/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Introduction: Neuromuscular blocking agents are widely used to facilitate endotracheal intubation, ease mechanical ventilation, and optimize surgical conditions. Neostigmine is a commonly used acetylcholinesterase inhibitor,which competitively antagonizes residual neuromuscular blockade by preventing metabolism of acetylcholine.Sugammadex is a gamma-cyclodextrin drug that reverses non-depolarising neuromuscular blockade, induced Vecuronium.It has been compared with acetyl-cholinesterase inhibitors, mainly Neostigmine. Sugammadex, unlike Neostigmine, does not inhibit acetylcholinesterase, hence co-administration of an antimuscarinic agent is not needed.We propose to undertake this study to compare the time taken to recover from neuromuscular blockade. Aim and Objectives: 1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for reversal of Vecuronium induced neuromuscular blockade. 2.To compare the efficacy of study drug administration to time of recovery of TOFr to 0.9 and clinical signs of recovery after tracheal extubation. Material and Methods: This will be a double blinded and randomized controlled trial conducted on 84 patients undergoing elective surgery at Christian Medical College & Hospital, Ludhiana. The patients will be divided into two groups of 42 patients each: Group A: Reversal with Sugammadex Group B: Reversal with Neostigimine plus Glycopyrronium bromide. |