| CTRI Number |
CTRI/2025/09/094869 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Doses of Sugammadex for Reversal of Muscle Relaxant Rocuronium in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of Two Different Doses of Sugammadex for Reversal of Rocuronium 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 |
Dr Annie Paul |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South West
DELHI
110029
India |
| Phone |
8368359292 |
| Fax |
|
| Email |
anniepaul1698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibhuti Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South West
DELHI
110029
India |
| Phone |
9810903924 |
| Fax |
|
| Email |
vibhuti411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibhuti Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South West
DELHI
110029
India |
| Phone |
9810903924 |
| Fax |
|
| Email |
vibhuti411@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Annie Paul |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital |
| 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 Annie Paul |
Department of Anaesthesia and Intensive Care, VMMC and SJH |
Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi
South West
DELHI |
8368359292
anniepaul1698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z418||Encounter for other procedures forpurposes other than remedying health state, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sugammadex 1mg per kg |
Drug: Sugammadex
Groups:
a) Group L will be 1mg per kg
b) Group H will be 2 mg per kg
Administered at TOF count 4 and TOFR less than 0.3 during neuromuscular monitoring |
| Intervention |
Sugammadex 1mg per kg or 2 mg per kg |
Sugammadex administered in two different doses, at 1mg per lg and 2mg per kg intravenous.
Administered at TOF count 4 and TOFR less than 0.3 during neuromuscular monitoring. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 or 2
Surgeries under general anaesthesia with controlled ventilation for equal or greater than 40 minutes duration |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to study drugs
Neuromuscular disorders
Medications altering effects of NMBA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time from administration of Sugammadex to achieving TOFR greater than 0.9 |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/10/2025 |
| 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
|
This study compares the efficacy of two doses of Sugammadex, 1mg per kg and 2mg per kg, a drug used to reverse Rocuronium induced neuromuscular blockade in surgical patients. Outcomes include time to full reversal, percentage achieving target within 5min. |