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To compare the effect of two medicines, amisulpride and ondansetron to see which works better in preventing nausea and vomiting after gallbladder removal surgery

Comparison of amisulpride and ondansetron for prevention of post operative nausea and vomiting following laparoscopic cholecystectomy - none

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094387
Enrollment
126
Registered
2025-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K810- Acute cholecystitis Health Condition 2: K812- Acute cholecystitis with chronic cholecystitis Health Condition 3: K811- Chronic cholecystitis Health Condition 4: K819- Cholecystitis, unspecified Health Condition 5: K800- Calculus of gallbladder with acutecholecystitis Health Condition 6: K801- Calculus of gallbladder with othercholecystitis Health Condition 7: K802- Calculus of gallbladder without cholecystitis Health Condition 8: K804- Calculus of bile duct with cholecy

Interventions

Intervention1: Amisulpride 5mg: Amisulpride 5mg given intravenously once 30 minutes before the induction of anaesthesia Control Intervention1: Ondansetron 8mg: Ondansetron 8mg given intravenously once

Sponsors

MS Ramaiah Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American society of anaesthesiologists ASA physical status 1 and 2 weight 40kg to 70kg

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To compare the incidence of postoperative nausea and vomiting following premedication with amisulpride and ondansetron in patients undergoing laparoscopic cholecystectomyTimepoint: 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

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Tejesh C A

MS Ramaiah Medical College

drtejeshca@yahoo.com9886481848

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026