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Comparing two medicines, amisulpride and palonosetron, to see which better prevents nausea and vomiting in patients after laparoscopic gallbladder removal.

To compare efficacy of prevention of post operative nausea and vomiting between amisulpride and palonosetron in patients undergoing laparoscopic cholecystectomy. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095118
Enrollment
268
Registered
2025-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Amisulpride: Intravenous Amisulpride 10 mg, given as a slow IV injection at induction of anesthesia in patients undergoing elective laparoscopic cholecystectomy. Control Intervention1:

Sponsors

Dr Saloni Das
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults of either sex ASA Physical Status I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

Exclusion criteria: Patients will be excluded if they refuse consent OR belong to ASA physical status class III or IV OR are undergoing emergency laparoscopic surgery OR are smokers or alcoholics OR are pregnant or lactating OR have a history of postoperative nausea/vomiting or motion sickness OR are allergic to amisulpride or palonosetron OR have significant liver or renal disease OR are already on antiemetics, steroids, or psychomimetic drugs preoperatively OR if the surgery duration is greter than or equal to 3 hours

Design outcomes

Primary

MeasureTime frame
1.To compare the incidence of nausea, vomiting and retching during post-operative 24 hrs in patients undergoing laparoscopic cholecystectomy. 2.To assess the severity of nausea and vomiting as recorded by PONV score. 3.The number and timing of doses of rescue antiemetic used during post op 24 hrs Timepoint: 10 MONTHS

Secondary

MeasureTime frame
To compare: 1. patient satisfaction score and 2. adverse effects related to study drugs. Timepoint: 10 MONTHS

Countries

India

Contacts

Public ContactDr Sulochana Dash

IMS & SUM Hospital

dr.silu76@gmail.com9566841303

Outcome results

None listed

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