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CTRI Number  CTRI/2024/09/074423 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Benifits of Amisulpride versus Ondansetron to prevent postoperative nausea and vomiting in surgical patients requiring general anaesthesia. 
Scientific Title of Study   To Study the Efficacy and Safety of Intravenous Amisulpride against Ondansetron in Post-Surgical Patients undergoing general Anaesthesia to Prevent Post Operative Nausea Vomiting (PONV)- An Interventional, Randomised, 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  Dr Tejash H Sharma 
Designation  Professor 
Affiliation  Dept. of Anaesthesiology, SBKS MIRC 
Address  Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University
B 15, Shyam Residency, TP 13, Vadodara
Vadodara
GUJARAT
391760
India 
Phone  9427332100  
Fax    
Email  drtejash@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejash H Sharma 
Designation  Professor 
Affiliation  Dept. of Anaesthesiology, SBKS MI RC 
Address  Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University
B 15, Shyam Residency, TP 13, Vadodara
Vadodara
GUJARAT
391760
India 
Phone  9427332100  
Fax    
Email  drtejash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tejash H Sharma 
Designation  Professor 
Affiliation  Dept. Of Anaesthesiology, SBKS MIRC 
Address  Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University
B 15, Shyam Residency, TP 13, Vadodara
Vadodara
GUJARAT
391760
India 
Phone  9427332100  
Fax    
Email  drtejash@gmail.com  
 
Source of Monetary or Material Support  
Sumandeep Vidyapeeth Deemed to be University, Waghodiya road, Piparia, Taluka Wahodiya, Pin code- 391760 Dist Vadodara, Gujarat, India 
 
Primary Sponsor  
Name  Sumandeep Vidyapeeth Deemed to be Univeersity 
Address  Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta. Waghodiya, Pincode 391760, Vadodara, Gujarat, India 
Type of Sponsor  Private medical college 
 
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 Tejash Sharma  Dhiraj Hospital, Sumandeep Vidyapeeth Deemed to be University  Dhiraj Hospital, Sumandeep Vidyapeeth Deemed to be University, Piparia, Vadodara, Gujarat, 391760, India.
Vadodara
GUJARAT 		 9427332100

DRTEJASH@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AMISULPRIDE  Anti emetic Dopamine 2 receptor blocker, shall be given prior to anaesthesia as premedication. Post operative nausea vomiting shall be assessed after completion of surgery at 0, 2, 6 8, 12, 24 and 48 hours. 
Comparator Agent  ONDANSETRON  Anti emetic 5HT3 receptor blocker, shall be given prior to anaesthesia as premedication. Post operative nausea vomiting shall be assessed after completion of surgery at 0, 2, 6 8, 12, 24 and 48 hours. 
 
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  If any antihistaminic, continuous infusion of propofol or dexmedetomidine, steroids, any antiemetics is used 24 hours prior or post-surgery then the case will be not selected for the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Complete response of medicine that is no episodes of emesis and no use of rescue medication in first 24 hours after wound closure or PONV.  0,2,6,8,12,24,48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the incidence of nausea, emesis, use of rescue medication any adverse event.  0,2,6,8,12,24,48 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   07/10/2024 
Date of Study Completion (India) 21/01/2025 
Date of First Enrollment (Global)  07/10/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  drtejash@gmail.com

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 31-12-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Traditionally ondansetron is used as an antiemetic to prevent post-operative nausea and vomiting (PONV), which is a 5HT3 Receptor blocker. Amisulpride is a dopamine receptor antagonist with less incidence of extrapyramidal symptoms in a safe dose range from 50- 1200 mg. Now it is recently available as (Sultran 5mg/ 2ml preparation in India) an antiemetic drug to prevent post-operative nausea and vomiting. So we have to study the efficacy and safety of intravenous amisulpride against ondansetron in post-surgical patients undergoing general anaesthesia to prevent post-operative nausea and vomiting (PONV).

 
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