| CTRI Number |
CTRI/2025/11/097988 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing effect of two drugs (Sugammadex and Neostigmine) in reducing incidence of muscle weakness after reversal of anesthesia in patients undergoing surgery |
|
Scientific Title of Study
|
A prospective randomized comparative study on the Effects of Sugammadex vs Neostigmine on incidence of postoperative residual 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 |
Rakshita Sah |
| Designation |
DNB Resident Anesthesiology |
| Affiliation |
Max Smart Super Speciality Hospital, Saket |
| Address |
Department of Anaesthesiology and Pain Management, Max Smart Super Speciality Hospital, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9012990737 |
| Fax |
|
| Email |
rsah96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Kumar Fotedar |
| Designation |
Senior Director and Clinical Coordinator, Department of Anaesthesiology and Pain Medicine |
| Affiliation |
Max Smart Super Speciality Hospital, Saket |
| Address |
Department of Anaesthesiology and Pain Management, Max Smart Super Speciality Hospital, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9873003832 |
| Fax |
|
| Email |
kamal.fotedar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Kumar Fotedar |
| Designation |
Senior Director and Clinical Coordinator, Department of Anaesthesiology and Pain Medicine |
| Affiliation |
Max Smart Super Speciality Hospital, Saket |
| Address |
Department of Anaesthesiology and Pain Management, Max Smart Super Speciality Hospital, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9873003832 |
| Fax |
|
| Email |
kamal.fotedar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Smart Superspeciality Hospital, 1,2 Press Enclave Road, Saket, New Delhi, 110017 India |
|
|
Primary Sponsor
|
| Name |
Rakshita Sah |
| Address |
Department of Anaesthesiology and Pain Management, Max Smart Super Speciality Hospital, Saket, New Delhi, 110017 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Max Smart Super Speciality Hospital Saket |
MAX SMART SUPERSPECIALITY HOSPITAL
1, 2 PRESS ENCLAVE ROAD
SAKET, NEW DELHI 110017
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakshita Sah |
Max Smart Super Speciality Hospital, Saket |
OT 1 - 12
OT Complex 1st floor and OT Complex 2nd floor, Department of Anaesthesiology
South
DELHI |
9012990737
rsah96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAX HEALTHCARE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (5) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NEOSTIGMINE |
50 mcg/kg with glycopyrrolate if 1-3 TOF count
or
100 mcg/kg with glycopyrrolate if extubation criteria not achieved
Given as bolus dose after end of surgery to reverse neuromuscular blockade based on above mentioned dose |
| Intervention |
SUGAMMADEX |
2mg/kg if 1-3 TOF
or
4 mg/kg if extubation criteria not achieved
Given as bolus dose after end of surgery to reverse neuromuscular blockade based on above mentioned dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class 1-3
Elective Non cardiac, non neurologic surgery under general anesthesia with rocuronium |
|
| ExclusionCriteria |
| Details |
Refusal or inability to consent.
ASA IV or higher.
Unstable cardiac or respiratory disease.
BMI more than 30 kg per meter squared.
Pregnancy or nursing.
Emergency surgery or major protocol deviations.
Intraoperative adverse events requiring intervention.
Known neuromuscular disorders like myasthenia gravis
Severe hepatic or renal failure.
Allergy to study drugs
History or family history of malignant hyperthermia
Use of medications affecting NMB like magnesium, physostigmine
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of RNMB (TOF less than 0.90) on PACU (Post anesthesia care unit)
|
Baseline
1 min
2 min
3 min
4 min
5 min
10 min
15 min
20 min
25 min
30 min
Optional - further every 5 min till PACU exit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to OR Discharge Readiness |
Administration of reversal agent to OR discharge |
| Post operative Pulmonary Complications |
During PACU stay |
| Time from PACU arrival to Discharge Readiness |
PACU arrival time
PACU discharge time |
| Neuromuscular Recovery Metrics |
Time to achieve TOF more than 0.9 if not at extubation |
| Adverse Events (Bradycardia, Arrhythmias, Anaphylaxis, Hypertension, Nausea, Vomiting, Recurarisation) |
Till PACU Discharge
Recurarisation will be observed for 2 hours |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/12/2026 |
| 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)
|
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
|
Residual Neuromuscular Blockade after surgery is a prevalent yet under recognised perioperative risk which increases post operative pulmonary complications, prolongs post anesthesia care unit stay and reduces patient satisfaction. This study aims to compare sugammadex and neostigmine in
typical adult surgical patients to determine if sugammadex significantly lowers
RNMB incidence and improves recovery. Demonstrating such a benefit could drive
practice change and enhance patient safety. |