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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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

 
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