| CTRI Number |
CTRI/2024/10/074937 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 drugs in general anaesthesia for their side effects , time taken for recovery from neuromuscular paralysis |
|
Scientific Title of Study
|
Comparison of Sugammadex vs Neostigmine in Reversal of Vecuronium induced Neuromuscular blockade |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Sharma |
| Designation |
Junior resident |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
Department Of Anaesthesia Sardar Patel Medical College Bikaner Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
7737382741 |
| Fax |
|
| Email |
dr.mohit5695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Pareek |
| Designation |
Additional Principal and Head of Department |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
Department Of Anaesthesia Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Anita Pareek |
| Designation |
Additional Principal and Head of Department |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
Department Of Anaesthesia Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College , Bikaner,Pincode 334001 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner |
| Address |
Department Of Anaesthesia Sardar Patel Medical College Bikaner Pincode 334001 Rajasthan India |
| Type of Sponsor |
Government 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 Mohit Sharma |
Sardar Patel medical college |
Department of
Anaesthesia,
Sardar Patel Medical
College, Bikaner,
Rajasthan
Bikaner
RAJASTHAN |
7737382741
dr.mohit5695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Research Board , SPMC Bikaner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (4) ICD-10 Condition: E069||Thyroiditis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General Anaesthesia |
Injecting reversal agent at the end of surgery for neuromuscular recovery under 2 hours |
| Comparator Agent |
Sugammadex vs Neostigmine |
Comparison of IV Sugammadex(2mg/kg) vs IV Neostigmine(0.05 mg/kg) in Reversal of Vecuronium induced Neuromuscular blockade undergoing elective surgeries under 2 hours |
|
|
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.
Stable medical condition(ASA grade l and II):
Ability to provide informed consent . |
|
| ExclusionCriteria |
| Details |
Allergy or contraindication to Sugammadex ,Neostigmine.
Unstable medical conditions (ASA grade III and IV)
Recent exposure to neuromuscular blocking agents:
Pregnancy or breastfeeding.
Patients with Neuromuscular disorders
Inability to provide informed consent.
Participation in other studies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the time taken for recovery of neuromuscular function (time to train-of-four ratio ≥ 0.9) after administration of Sugammadex versus Neostigmine.
To compare the quality of neuromuscular recovery between Sugammadex and Neostigmine, including parameters such as the return of spontaneous ventilation, muscle strength, and reversal completeness. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the time to extubation after the administration of Sugammadex versus Neostigmine.
To evaluate the incidence of adverse events associated with the use of Sugammadex and Neostigmine, including but not limited to respiratory complications, cardiovascular events, and allergic reactions. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 4 |
|
Date of First Enrollment (India)
|
19/10/2024 |
| 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="0"
Months="6"
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
|
Neuromuscular blocking drugs (NMBDs) are used extensively for facilitating surgical procedures and tracheal intubation during anaesthesia, concerns have been raised about the risks of postoperative residual neuromuscular blockade.Acetylcholinesterase inhibitors, such as neostigmine and edrophonium, are used for the reversal of nondepolarizing neuromuscular blockade, but they carry a risk of unwanted effects.Sugammadex, a water-soluble, modified γ-cyclodextrin, is a novel drug developed specifically for the rapid reversal of neuromuscular blockade induced by the steroidal NMBD rocuronium. Sugammadex acts by encapsulating unbound rocuronium and, to a lesser extent, also vecuronium molecules, and reducing the free NMBD fraction at the neuromuscular junction.The present study is designed to compare the efficacy and side effects of sugammadex versus neostigmine, for vecuronium-induced neuromuscular blockade in patients scheduled for elective surgery under sevoflurane anesthesia. |