| CTRI Number |
CTRI/2026/03/106726 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Compare the efficacy between amisulpride and dexamethasone in post operative nausea and combating |
|
Scientific Title of Study
|
To Compare the Efficacy and Safety of Intravenous Amisulpride Against Dexamethasone in Post-Surgical Patients to Prevent Post-Operative Nausea and Vomiting (PONV): A Randomized, Controlled, Prospective 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 |
Reena Kankotiya |
| Designation |
Junior resident (1 st year ), Department of anesthesiology |
| Affiliation |
Sumandeep vidhyapeeth |
| Address |
Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Sumandeep Vidyapeeth, Pipariya, Vaghodiya, Vadodara, Gujarat – 391760, India. Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Sumandeep Vidyapeeth, Pipariya, Vaghodiya, Vadodara, Gujarat – 391760, India. Vadodara GUJARAT 391760 India |
| Phone |
8779455374 |
| Fax |
|
| Email |
Reenakankotiya008@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Reena Kankotiya |
| Designation |
First year resident in anaesthesia |
| Affiliation |
Sumandeep vidhyapeeth |
| Address |
Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Sumandeep Vidyapeeth, Pipariya, Vaghodiya, Vadodara, Gujarat – 391760, India. Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Sumandeep Vidyapeeth, Pipariya, Vaghodiya, Vadodara, Gujarat – 391760, India. Vadodara GUJARAT 391760 India |
| Phone |
8779455374 |
| Fax |
|
| Email |
Reenakankotiya008@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Reena Kankotiya |
| Designation |
First year resident in anaesthesia |
| Affiliation |
Sumandeep vidhyapeeth |
| Address |
Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Sumandeep Vidyapeeth, Pipariya, Vaghodiya, Vadodara, Gujarat – 391760, India. Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Sumandeep Vidyapeeth, Pipariya, Vaghodiya, Vadodara, Gujarat – 391760, India. Vadodara GUJARAT 391760 India |
| Phone |
8779455374 |
| Fax |
|
| Email |
Reenakankotiya008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumandeep vidyapeeth pipariya waghodiya 391760 |
|
|
Primary Sponsor
|
| Name |
Reena Kankotiya |
| Address |
Sumandeep vidhyapeeth pipariya,vaghodiya,Gujarat,397160 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Reena Kankotiya |
Sumandeep vidhyapeeth , Dhiraj hospital |
Room No. 8, Doctor Quarter, Department of Anaesthesiology, Division of Anaesthesiology, Vadodara GUJARAT |
8779455374
Reenakankotiya008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R112||Nausea with vomiting, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
administration of intravenous antiemetic drugs |
The intervention in this study consists of administration of intravenous antiemetic drugs, where patients in one group receive intravenous amisulpride and those in the other group receive intravenous dexamethasone for prevention of postoperative nausea and vomiting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
: Surgery to last at least 1 hour
:Overnight stay
:General anaesthesia
:ASA I&II
:At least one of the following Apfel et al’s risk factors for PONV:
Female sex
Non-smoking status
A prior history of PONV or motion sickness
Being expected to receive postoperative opioid analgesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving complete response (no nausea, no vomiting, and no requirement for rescue antiemetic) within the first 24 hours after surgery. |
0–2 hours postoperatively
2–6 hours postoperatively
6–24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2026 |
| 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
|
Postoperative nausea and vomiting is a common and distressing complication following surgery and anesthesia, leading to patient discomfort, delayed recovery, and increased healthcare costs. Various pharmacological agents are used for its prevention, among which dexamethasone is widely employed. Amisulpride, a selective dopamine receptor antagonist, has recently emerged as a potential alternative for Post operative nausea and vomiting prophylaxis.
This prospective, randomized, controlled study aims to compare the efficacy and safety of intravenous amisulpride with intravenous dexamethasone in preventing post operative nausea and vomiting in post-surgical patients. Eligible patients undergoing surgery under general anesthesia will be randomly allocated into two groups to receive either intravenous amisulpride or dexamethasone intraoperatively. The primary outcome will be the incidence of postoperative nausea and vomiting within the first twenty four hours after surgery. Secondary outcomes will include severity of nausea, need for rescue antiemetics, and incidence of adverse effects.
The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of intravenous amisulpride versus dexamethasone, thereby aiding anesthesiologists in selecting optimal prophylactic therapy for Post operative nausea and vomiting |