| CTRI Number |
CTRI/2025/12/099031 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| 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 two drugs that help restore muscle strength after an operation |
|
Scientific Title of Study
|
Sugammadex vs Neostigmine for Reversal of Neuromuscular Blockade: Recovery Profile and Postoperative Complication |
| 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 S Shanu |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8056603011 |
| Fax |
|
| Email |
shanushanmugasundaram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Shanu |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8056603011 |
| Fax |
|
| Email |
shanushanmugasundaram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harihar Pratap |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9446582486 |
| Fax |
|
| Email |
hariharpradap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Sankari Main Road (NH-47), Ariyanoor/Seeragapadi, Salem - 636308, Tamil Nadu, India, |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals , Chinnaseeragapadi Sankari Main Road (NH-47), Ariyanoor/Seeragapadi, Salem - 636 308, Tamil Nadu, 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 Harihar Pratap |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Door no 14 , Department of Anesthesiology Vinayaka Missions
Kirupananda Variyar Medical College and
Hospitals Chinnaseeragapadi
Salem
TAMIL NADU |
9446582486
hariharpradap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 |
| Comparator Agent |
Neostigmine + Glycopyrrolate |
Neostigmine will be administered in a single intravenous dose of 0.05 mg per kg along with glycopyrrolate 0.01 mg per kg at the end of surgery. The combination is given once as an intravenous bolus. The duration of action extends until recovery of neuromuscular function, typically between five to twenty minutes depending on the depth of block. |
| Intervention |
Sugammadex |
Sugammadex will be administered as a single intravenous dose of 2 mg per kg at the end of surgery. The drug is given once as a bolus through the intravenous line. Its clinical effect lasts until full reversal of neuromuscular blockade is achieved, usually within a few minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I and II
2.Elective surgeries with vecuronium
3.Informed consent
|
|
| ExclusionCriteria |
| Details |
1.Neuromuscular disorders
2.Hepatic/renal dysfunction
3.Known allergy to study drugs
4.Pregnancy/lactation
|
|
|
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 |
| To assess the time taken to reach TOF ratio more than or equal to 0.9 after administration of each agent |
Measured from time of reversal with TOF ratio recorded every 1 minute until TOF more than or equal to 0.9. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of postoperative nausea and vomiting , dyspnea , diplopia inability to sustain head lift and urinary retention. |
Recovery milestones recorded every 1 minute until achieved, and postoperative complications assessed at 0, 15, 30, 60, 120 minutes, then at 6 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/12/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 compares Sugammadex and Neostigmine for the reversal of neuromuscular blockade in patients undergoing general anesthesia. The aim is to evaluate which drug provides faster and more reliable recovery of muscle function and to assess the incidence of postoperative complications. The primary outcome is the time taken to achieve adequate neuromuscular recovery after administration of the reversal agent. Secondary outcomes include extubation time, return of clinical recovery signs, and postoperative events such as nausea, vomiting, desaturation, bradycardia, diplopia, and urinary retention during the first twenty four hours. This study will help determine whether Sugammadex offers significant clinical advantages over neostigmine in routine anesthesia practice. |