| CTRI Number |
CTRI/2025/10/095880 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effects two different anaesthetic drugs on postoperative nausea and vomiting in ENT Surgery |
|
Scientific Title of Study
|
Effects of Sugammadex and Neostigmine-glycopyrrolate on postoperative Nausea and Vomiting in ENT Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nibedita Hazarika |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati medical college and hospital |
| Address |
Department of Anesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
6003416868 |
| Fax |
|
| Email |
nibeditahzrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor and Head of department Anaesthesiology and Critical care |
| Affiliation |
Gauhati medical college and hospital |
| Address |
Department of Anesthesiology and Critical Care, Gauhati Medical College and Hospital,Bhangagarh,Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor and Head of department Anaesthesiology and Critical care |
| Affiliation |
Gauhati medical college and hospital |
| Address |
Department of Anesthesiology and Critical Care, Gauhati Medical College and Hospital,Bhangagarh,Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College And Hospital,Bhangagarh,Guwahati-781032 |
|
|
Primary Sponsor
|
| Name |
Nibedita Hazarika |
| Address |
Department of Anesthesiology,Gauhati Medical College and Hospital,Bhangagarh,Guwahati |
| Type of Sponsor |
Other [Self] |
|
|
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 Nibedita Hazarika |
Gauhati medical college and hospital |
Department of Anesthesiology and critical care, Gauhati Medical college and hospital,
Bhangagarh, Gauhati,
Ear nose Throat Major Operation Theatre
Kamrup
ASSAM |
60034 16868
nibeditahzrk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,gauhati medical college and hospital |
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
|
Intravenous injection- Neostigmine0.05mg per kg body weight and Glycopyrolate0.01 mg per kg body weight admixture will be used as agent for neuromuscular block reversal |
| Intervention |
SUGAMMADEX |
Intravenous injection SUGAMMADEX 2mg per kg body weight will be used as agent for neuromuscular block reversal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient undergoing elective ear,nose,throat surgeries under general anesthesia
2. ASA grade 1,2
3.Patient who have given written and informed consent
4.Patient with no history of PONV
|
|
| ExclusionCriteria |
| Details |
1.Emergency surgery
2.Pregnant female
3.ASA grade 3 and above
4.Patient with incapacity to consent
5.Patient requiring post operative ventilation
6.History suggestive of hypersensitivity to drugs
used in the study
7.Patients with impaired renal function
Patient with impaired renal function
Patient who underwent middle ear surgery requiring nerve monitoring |
|
|
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 compare the effects of Sugammadex on post operative nausea and vomiting with those of Neostigmine glycopyrolate mixture during the first 24 hours |
To compare the effects of Sugammadex on post operative nausea and vomiting with those of Neostigmine glycopyrolate mixture during the first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess incidence of acute post operative complications such as hemoglobin desaturation, tracheal re intubation and unexpected I.C.U admission after reversal with SUgammadex or Neostigmine glycopyrolate mixture |
Within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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)
|
19/11/2025 |
| 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)
|
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 is a prospective double blinded randomized control study to be conducted in the department of ENT major operation theatres of Gauhati Medical college and hospital under the department of Anaesthesiology and Critical care,GMCH.The study will be carried out on adult patients of both sexes posted for ENT surgery. The aim of the study is to compare the effects of Sugammadex and Neostigmine glycopyrolate mixture as reversal agents on the incidence of post operative nausea and vomiting during the first 24 hours following in ear, nose, throat surgery.The secondary objective of the study is to assess incidence of acute postoperative complications such as hemoglobin desaturation, tracheal re intubation and unexpected I.C.U admission after reversal with Sugammadex or Neostigmine glycopyrolate mixturte. |