| CTRI Number |
CTRI/2026/01/100274 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two doses of sugammadex for safe removal of the breathing tube after ENT surgeries. |
|
Scientific Title of Study
|
Comparison of Efficacy of two different doses of sugammadex for Extubation in ENT surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakash Sharma |
| Designation |
PG student |
| Affiliation |
Mahatma Gandhi medical College and hospital |
| Address |
2nd floor OT complex Department of Anaesthesia at Mahatma Gandhi medical College and hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7232096288 |
| Fax |
|
| Email |
prakash.pims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuresh Kumar Bhargava |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi medical college and hospital |
| Address |
2nd floor OT complex Department of Anaesthesia at Mahatma Gandhi medical college and hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829063830 |
| Fax |
|
| Email |
suresh3559@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSuresh Kumar Bhargava |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi medical college and hospital |
| Address |
2nd floor OT complex Department of Anaesthesia at Mahatma Gandhi medical college and hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829063830 |
| Fax |
|
| Email |
suresh3559@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
India educational trust department of Anesthesia Mahatma Gandhi medical college and Hospital |
| Address |
RIICO industrial area,sitapura,tonk road,jaipur,Rajasthan,India,302022 |
| 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 |
| prakash sharma |
Mahatma Gandhi medical college and hospital |
2nd floor OT complex Department of Anaesthesia at Mahatma Gandhi medical college and hospital Sitapura jaipur
Jaipur
RAJASTHAN |
7232096288
prakash.pims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, (2) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sugammadex |
Patients in this group will recieve Sugammadex 2mg/kg intravenous bolus for reversal of neuromuscular blockade at the end of ENT surgry,after achieving at least two twitches on train of four(TOF)monitoring.Extubation will be performed after adequate recovery of neuromuscular function and fulfillment of standard extubation criteria. |
| Comparator Agent |
Sugammadex |
Patients in this group will recieve Sugammadex 4mg/kg intravenous bolus for reversal of neuromuscular blockade at the end of ENT surgery,after achieving at least two twitches on train of four(TOF)monitoring.Extubation will be performed afteradequate recovery of neuromuscular function and fulfillment of standard extubation criteria. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patients who are willing to participate in this study by written and informed consent 2.patients of either sex having age 18-65 years 3.Patients of ASA grade 1 and 2 4.patients undergoing elective ENT surgeries under GA |
|
| ExclusionCriteria |
| Details |
1.History of drug allergy
2.Chronic opioid users
3.History of neurological or psychiatric illness
4.Previous known neuromuscular disease
5.Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time (in seconds) from intravenous administration of Sugammadex to successful tracheal extubation |
Measured from administration of Sugammadex until extubation,up to 15 minutes post administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate(bpm),blood pressure(mm hg) changes following sugammadex administration. |
Baseline( before Sugammadex).
2,5,10,15 minutes after Sugammadex administration. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
15/01/2026 |
| 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="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
|
Neuromuscular blockade is an essential component of modern anaesthesia practice allowing for optimal surgical conditions and facilitating endotracheal intubation.However the reversal of neuromuscular blockade at the end of surgery is crucial to avoid post operative residual curarisation which is associated with significant morbidity including respiratory complications,airway obstruction and prolonged recovery time. Despite the widespread use of anticholinesterase agents such as Neostigmine combined with anticholinergic drugs like Glycopyrolate these agents have limitations including incomplete or delayed reversal,muscarinic side effects(Salivation,Lacrimation,Bronchoconstriction,Bradycardia,Urinary incontinence).
To overcome these limitations,sugammadex a selective relaxant binding agent was introduced into clinical practice,,it was developed specifically to reverse the effect of steroidal non depolarizing muscle relaxant like Rocuronium and Vecuronium. Sugammadex is a modified gamma cyclodextrin that encapsulates steroidal neuromuscular blocking agents (NMBA) molecules in the plasma rendering them inactive.This encapsulation rapidly decreases the free concentration of the muscle relaxant,creating a concentration gradiant that draws more of the drug from the NM junction back into the plasma.This results in efficiently reversal of blockade within minutes regardless of the depth of the block. |