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CTRI Number  CTRI/2025/09/094387 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 05/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of two medicines, amisulpride and ondansetron to see which works better in preventing nausea and vomiting after gallbladder removal surgery 
Scientific Title of Study   Comparison of amisulpride and ondansetron for prevention of post operative nausea and vomiting following laparoscopic cholecystectomy 
Trial Acronym  none 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srushti Shankar Hireraddi 
Designation  PG resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital MSRIT Post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9740389089  
Fax    
Email  srushtihireraddi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital MSRIT Post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital MSRIT Post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College Bangalore MSRIT post New Bel road Bangalore 560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical College 
Address  New BEL Road MSRIT Post Bangalore 560054 
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 Srushti Shankar Hireraddi  MS Ramaiah Medical College Hospital  Department of Anaesthesiology Second floor MS Ramaiah Medical College Hospital New BEL Road
Bangalore
KARNATAKA 
9740389089

srushtihireraddi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MS Ramaiah Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis, (2) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (3) ICD-10 Condition: K811||Chronic cholecystitis, (4) ICD-10 Condition: K819||Cholecystitis, unspecified, (5) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (6) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (7) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (8) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (9) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (10) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (11) ICD-10 Condition: K808||Other cholelithiasis, (12) ICD-10 Condition: K820||Obstruction of gallbladder, (13) ICD-10 Condition: K821||Hydrops of gallbladder, (14) ICD-10 Condition: K822||Perforation of gallbladder, (15) ICD-10 Condition: K824||Cholesterolosis of gallbladder, (16) ICD-10 Condition: K823||Fistula of gallbladder, (17) ICD-10 Condition: K828||Other specified diseases of gallbladder, (18) ICD-10 Condition: K829||Disease of gallbladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amisulpride 5mg  Amisulpride 5mg given intravenously once 30 minutes before the induction of anaesthesia 
Comparator Agent  Ondansetron 8mg  Ondansetron 8mg given intravenously once 30 minutes before the induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of anaesthesiologists ASA physical status 1 and 2
weight 40kg to 70kg 
 
ExclusionCriteria 
Details  Patient refusal
Patients with known allergy to study drug
Patients coming for any emergency surgeries
Patient with history of motion sickness or dizziness or vestibular disease
Known prolactin dependent tumour or phaeochromocytoma
Documented clinically significant cardiac arrythmia or long QT syndrome
Pregnant or breastfeeding
History of epilepsy, parkinsons, treatment with levodopa
Received any emetogenic anticancer therapy in previous 4 weeks
Pre existing nausea or vomiting in the 24 hours before surgery
Patients being treated with regular antiemetic therapy including systemic corticosteroids 
 
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 the incidence of postoperative nausea and vomiting following premedication with amisulpride and ondansetron in patients undergoing laparoscopic cholecystectomy  Nausea and vomiting assessed postoperatively at the following time points
2hours after surgery
6 hours after surgery
12 hours after surgery
24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/10/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [srushtihireraddi@gmail.com].

  6. For how long will this data be available start date provided 01-10-2027 and end date provided 01-10-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Laparoscopic cholecystectomy is one of the most common surgical procedures performed for the removal of the gallbladder. The most common post operative problem reported after laparoscopic cholecystectomy is nausea and vomiting with prevalence of 27.7 percent.

Postoperative nausea and vomiting (PONV) causes dehydration, electrolyte imbalance and leads to discomfort and extended hospital stay. It also increases the risk of complications like aspiration pneumonia and wound dehiscence. Overall, it reduces the quality of life of patients and adds considerably to resource use and costs.

Several agents like 5HT3 antagonists, metoclopramide and domperidone are widely used as prophylaxis for postoperative nausea and vomiting but they are associated with sedation and extrapyramidal symptoms. Amisulpride is a selective dopamine (D2 and D3) antagonist that has been shown to be effective as a prophylactic antiemetic as well as a rescue treatment for postoperative nausea and vomiting. It has a better safety profile and more targeted action on D2 receptors in Chemoreceptor trigger zone of brain. It also has an additional benefit of minimal QT prolongation, which was a major concern with other D2 antagonists like droperidol.

Ondansetron is a 5HT3 receptor antagonist, which is considered to be very effective for postoperative nausea and vomiting management. Studies have shown promising results with amisulpride for postoperative nausea and vomiting in various clinical settings, but its application specifically in laparoscopic cholecystectomy remains unexplored. Studies comparing amisulpride with other antiemetics like ondansetron are lacking, hence this study comparing the efficacy of amisulpride to ondansetron is needed. The present study was designed to test the hypothesis that a single, preoperative 5mg IV dose of amisulpride was more effective than a single, preoperative 8mg IV dose of ondansetron at preventing PONV in adults undergoing laparoscopic cholecystectomy.

 
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