| CTRI Number |
CTRI/2026/03/106322 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two medicines named Sugammadex and Neostigmine used to reverse muscle relaxation after general anaesthesia. Also their effect of nausea and vomiting after surgery, will be studied. |
|
Scientific Title of Study
|
Comparison of the effect of the Neuro Muscular reversal agents, sugammadex and neostigmine on postoperative nausea and vomiting in patients undergoing surgeries under general anaesthesia |
| 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 Vrajkumar Maheshwari |
| Designation |
PG Resident, Department of Anaesthesia |
| Affiliation |
Parul Institute of Medical Sciences and Research |
| Address |
117-A, Department of Anaesthesia, Parul Sevashram Hospital, P.O. Limda, Tal: Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9427648600 |
| Fax |
|
| Email |
vrajmaheshwari98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Chhaya |
| Designation |
Professor , Department of Anesthesia |
| Affiliation |
Parul Institute of Medical Sciences and Research |
| Address |
117-A, Department of Anaesthesia, Parul Sevashram Hospital, P.O. Limda, Tal: Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824233654 |
| Fax |
|
| Email |
dr.a.m.chhaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrajkumar Maheshwari |
| Designation |
PG Resident, Department of Anaesthesia |
| Affiliation |
Parul Institute of Medical Sciences and Research |
| Address |
117-A, Department of Anaesthesia, Parul Sevashram Hospital, P.O. Limda, Tal: Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9427648600 |
| Fax |
|
| Email |
vrajmaheshwari98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Medical Sciences and Research, Parul Sevashram Hospital, Vadodara, Gujarat, 391760, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Vrajkumar Maheshwari |
Parul Sevashram Hospital |
117-A, Department of Anesthesia, P.o. Limda, Parul University, Waghodia, Vadodara, Gujarat
Vadodara
GUJARAT |
9427648600
vrajmaheshwari98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research (PU-IECHR) |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Neostigmine 50 mcg/kg with injection Glycopyrrolate 10 mcg/kg combination intravenous will be given to reverse the effect of injection Vecuronium induced neuromuscular blockage . |
Incidence and severity of Post operative Nausea and Vomiting will be observe immediately in post operative recovery unit, 1hour, 6 hour, 12 hour, 24 hour after surgery and
to monitor adverse event if any. Rescue anti ematic will be given if needed. |
| Intervention |
Injection Sugammadex 2mg/kg intravenous will be administered to reverse the effect of injection Vecuronium induced neuromuscular blockage . |
Incidence and severity of Post operative Nausea and Vomiting will be observe immediately in post operative recovery unit, 1hour, 6 hour, 12 hour, 24 hour after surgery and
to monitor adverse event if any. Rescue anti ematic will be given if needed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Either gender.
Patients under ASA grade I, II.
Patients scheduled for surgeries to be performed under general anaesthesia.
Patients willing to sign written informed consent.
Patients ready to comply with perioperative fasting guidelines and protocols.
|
|
| ExclusionCriteria |
| Details |
Patients with grossly impaired cardio-respiratory, hepatic, and renal function.
Patients with known allergy any of the study drugs.
Patient experienced significant desaturation during induction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence and severity of Post Operative Nausea And vomiting. |
Immediately after surgery
1 hour after surgery
6 hour after surgery
12 hour after surgery
24 hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the need for rescue anti emetics.
To monitor adverse event if any.
|
Immediately after surgery
1 hour after surgery
6 hour after surgery
12 hour after surgery
24 hour after surgery |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
02/04/2026 |
| 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
|
After obtaining approval from the Clinical Trials Registry of India (CTRI), participant recruitment will commence in accordance with the predefined inclusion and exclusion criteria. A total of 104 participants will be enrolled and randomly allocated into two groups based on the study drugs. In group S patients will receive sugammadex 2mg/kg intravenous and group N patients will receive Neostigmine 50 mcg/kg with Glycopyrrolate 10 mcg/kg combination Intravenous, to reverse vecuronium induced neuromuscular blockage. The study objective is To compare the incidence of PONV, To compare severity of PONV, To compare the need for rescue anti emetics. To monitor adverse event if any.
(PONV: Post Operative Nausea and Vomiting) |