| CTRI Number |
CTRI/2025/10/096267 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Amisulpride–Ondansetron and Dexamethasone–Ondansetron to prevent nausea and vomiting after ear surgery |
|
Scientific Title of Study
|
Efficacy of combination of Amisulpride-Ondansetron Vs. Dexamethasone-Ondansetron to prevent post operative nausea vomiting in middle ear surgeries-A randomized controlled study |
| 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 Renita Anil |
| Designation |
Post graduate student |
| Affiliation |
St. Johns Medical college Hospital, Bangalore |
| Address |
2nd floor Operation theatre complex, Department of Anesthesia and
Critical Care, St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
8921798352 |
| Fax |
|
| Email |
renitaanil98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Manjuladevi |
| Designation |
Professor |
| Affiliation |
St. Johns Medical college Hospital, Bangalore |
| Address |
2nd floor Operation theatre complex,Department of Anesthesia and
Critical Care, St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9449059395 |
| Fax |
|
| Email |
drmanjula95@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renita Anil |
| Designation |
Post graduate student |
| Affiliation |
St. Johns Medical college Hospital, Bangalore |
| Address |
2nd floor Operation theatre complex, Department of Anesthesia and
Critical Care, St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
8921798352 |
| Fax |
|
| Email |
renitaanil98@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital Sarjapura Road Kormangala Bangalore-560034 |
|
|
Primary Sponsor
|
| Name |
Dr Renita Anil |
| Address |
St Johns Medical College Hospital Sarjapura Road Kormangala Bangalore 560034 |
| 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 Renita Anil |
St. Johns Medical college Hospital, Bangalore |
Room 9, 2nd floor ,
operation theatre
complex St. Johns
Medical college
Hospital, Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8921798352
renitaanil98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SJMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, (2) ICD-10 Condition: H669||Otitis media, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amisulpride |
To prevent post operative episodes of nausea and vomiting in middle ear surgeries for a period of 24 hours |
| Comparator Agent |
Dexamethasone-Ondansetron |
To prevent post operative episodes of nausea and vomiting in middle ear surgeries for a period of 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex and belonging to ASA I and II category, undergoing middle ear surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients who are pregnant,lactating,already on anti-emetics, history of psychiatric illness, central nervous system disorders, history of motion sickness, allergic to study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare incidence and severity of PONV in middle ear surgeries between the two drugs.
|
0,15min,30min,1 hr, 2hr,4 hr, 6 hr, 12hr, 18hr, 24hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Rescue anti-emetics used
2. Number of doses of rescue anti-emetics required
3. To analyse side effects of Amisulpride
4. Analgesia (Numerical Rating Scale)
5. Patient satisfaction (Discharge from PACU)
|
0,15min,30min,1 hr, 2hr,4 hr, 6 hr, 12hr, 18hr, 24hr |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/11/2025 |
| 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="2"
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
|
Patients undergoing middle ear surgeries are at a higher risk of post operative episodes of nausea and vomiting. Amisulpride a selective D2/D3 dopamine antagonist has gained attention as an effective anti-emetic treatment for PONV prophylaxis. This study aims to evaluate the efficacy of Amisulpride versus the combination of dexamethasone and ondansetron for the prevention of PONV in patients undergoing middle ear surgeries. Amisulpride may offer advantages in terms of efficacy and tolerability. We plan to conduct the study since there is a paucity of clinical research comparing these two drugs in middle ear surgeries. Our primary objective is to compare incidence and severity of PONV in middle ear surgeries between the two drugs and secondary objective includes (1) Rescue anti-emetics used (2) Number of doses of rescue anti-emetics required (3) To analyze side effects of Amisulpride (4) Analgesia (Numerical rating scale) (5) Patient satisfaction (Discharge from PACU)
|