| CTRI Number |
CTRI/2025/07/090212 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| 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 the effects of two injections on nausea and vomiting in patients after ear, nose, and throat surgeries. |
|
Scientific Title of Study
|
A randomised prospective comparative study of the effect of neostigmine 0.05mg per kg and sugammadex 2mg per kg on postoperative nausea and vomiting in adult patients under general anaesthesia in ear, nose, throat 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 |
Sarayu M Suresh |
| Designation |
Pg student, Anaesthesiology |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Department of Anaesthesia, 1st floor, room no 1, new stone building, KR Hospital, Irwin road, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9645243905 |
| Fax |
|
| Email |
sarayusuresh03828@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Y Srinivas |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Department of Anaesthesia, 1st floor, room no 1, new stone building, KR Hospital, Irwin road, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9353837014 |
| Fax |
|
| Email |
drsrinivasvy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Y Srinivas |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Department of Anaesthesia, 1st floor, room no 1, new stone building, KR Hospital, Irwin road, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9353837014 |
| Fax |
|
| Email |
drsrinivasvy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore Medical College and Research Institute, KR Hospital, Irwin road, Mysore, 570001 |
|
|
Primary Sponsor
|
| Name |
Mysore Medical College and Research Institute |
| Address |
Irwin road, next to railway station, Mysore, Karnataka 570001 |
| 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 Sarayu M Suresh |
Krishna Rajendra hospital |
Mysore Medical College and Research Institute, department of anaesthesiology, 1st floor, room no 1, new stone building, KR hospital, Irwin road, Mysore, Karnataka
Mysore
KARNATAKA |
9645243905
sarayusuresh03828@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mysore Medical College and Research Institute and associated hospitals, Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H701||Chronic mastoiditis, (2) ICD-10 Condition: J320||Chronic maxillary sinusitis, (3) ICD-10 Condition: J382||Nodules of vocal cords, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine |
Effect of Neostigmine 0.05mg/kg on post operative nausea and vomiting in adult patients under general anaesthesia in ear, nose, throat surgery |
| Intervention |
Sugammadex |
Effect of Sugammadex 2mg/kg on post operative nausea and vomiting in adult patients under general anaesthesia in ear, nose, throat surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 patients scheduled for elective ENT surgery with Apfel score 0 to 2 and BMI less than 30kg per m2 |
|
| ExclusionCriteria |
| Details |
Patients who were obese (body mass index greater than 30 kg per m2)
Pregnant
History of PONV
Apfel score more than 2
Impaired renal function (creatinine clearance less than 30ml per min)
Required postoperative ventilation
Allergic to any drugs used in the study
Patients who underwent middle ear surgery requiring nerve monitoring |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative nausea and vomiting
Amount of antiemetics given
Any other side effects |
1, 6, 12, 24 hours post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total antiemetic dosage administered and to assess the side effects after reversal with neostigmine and sugammadex in 24 hours. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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
|
The study is conducted to compare the effect of Sugammadex and Neostigmine on postoperative nausea and vomiting in adult patients under general anaesthesia in ear nose throat surgery. We also compare the amount of antiemetics given in the postoperative period and to know about the other side effects caused by these drugs, so that reversal agents can be decided for each case judiciously. |