| CTRI Number |
CTRI/2025/10/096381 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare two ways of giving the medicine Sugammadex — a fixed dose of 200 mg and a weight-based dose of 4 mg per kilogram — to see which works better and is safer for reversing muscle relaxation after general anesthesia in adult patients undergoing planned surgery. |
|
Scientific Title of Study
|
Comparative Efficacy and Safety of Fixed-Dose of 200 mg Versus Weight-Based 4 mg/kg Sugammadex for Reversal of Deep Neuromuscular Blockade in Adult Patients Undergoing Elective Surgery— 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)
|
| Name |
DR ABHA SINGH |
| Designation |
Assistant Professor |
| Affiliation |
United institute of medical sciences Prayagraj |
| Address |
room no 1 , department of anaesthesia & ot complex, 2 nd floor ,United institute of medical sciences, prayagraj , uttar pradesh
room no 1 , department of anaesthesia & ot complex, 2 nd floor ,United institute of medical sciences, prayagraj , uttar pradesh
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
9956742300 |
| Fax |
|
| Email |
drabhasingh1990@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHA SINGH |
| Designation |
Assistant Professor |
| Affiliation |
United institute of medical sciences Prayagraj |
| Address |
room no 1 , department of anaesthesia & ot complex, 2 nd floor ,United institute of medical sciences, prayagraj , uttar pradesh
room no 1 , department of anaesthesia & ot complex, 2 nd floor ,United institute of medical sciences, prayagraj , uttar pradesh
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
9956742300 |
| Fax |
|
| Email |
drabhasingh1990@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHA SINGH |
| Designation |
Assistant Professor |
| Affiliation |
United institute of medical sciences Prayagraj |
| Address |
room no 1 , department of anaesthesia & ot complex, 2 nd floor ,United institute of medical sciences, prayagraj , uttar pradesh
room no 1 , department of anaesthesia & ot complex, 2 nd floor ,United institute of medical sciences, prayagraj , uttar pradesh
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
9956742300 |
| Fax |
|
| Email |
drabhasingh1990@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abha Singh |
| Address |
United institute of medical sciences Prayagraj |
| Type of Sponsor |
Other [] |
|
|
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 Abha Singh |
united institute of medical sciences |
2 nd floor, Ot Complex, united institute of medical sciences, Prayagraj
Allahabad
UTTAR PRADESH |
9956742300
drabhasingh1990@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEEUNITEDINSTITUTEOFMEDICALSCIENCES |
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 |
intravenous injection of sugammadex |
the study drug will be given intravenously for the effect. |
| Comparator Agent |
two different doses of Sugammadex |
This study will be comparing two different doses of sugammadex that is fixed dose of 200mg with weight based dose of 4mg per kg body weight for reversing the anaesthsia in adult patients undergoing general anaesthesia. The drug will be given intravenously at the end of surgery and then response will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 75 years.
ASA physical status I to III.
Elective surgical procedure under general anaesthesia with planned use of continuous infusion/boluses of vecuronium resulting in deep block at end of procedure.
Intraoperative confirmation of deep block at time of reversal attempt(TOF count = 0 with 1 to 2 posttetanic counts PTC).
Ability to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
age less tha 18 years and more than 75 years
pregnant and lactating females
liver and renal failure
obese patients
neuromuscular disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.
|
Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving TOFR more than 0.90 within 3 min and within 3 to 5 min.
|
3 and 3 to 5 minutes |
Adverse events like allergic reactions, bradycardia , hypotension, arrhythmias, anaphylaxis, residual blockade.
|
no |
Cost analysis by calculating number of 200mg vials used per patient and estimated drug cost difference.
|
no |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
22/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is being done to compare the efficacy and safety of two different doses of sugammadex to reverse the effect of muscle paralysis of the patient at the end of surgery and the doses are fixed most commonly used dose of 200 mg with weight based dose calculation by 4 mg per kg . The effect of the drug will be noted with the help of neuromuscular transmission device with the help of adductor policis muscle and ulnar nerve . The time to achieve TOF Ratio of 0.8 and 0.9 will be noted with adverse event and cost analysis |