| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [srushtihireraddi@gmail.com].
- 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.
- 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. |