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Comparison of the drugs (amisulpride and dexamethasone) for prevention of nausea and vomiting in patients for removal of Gall Bladder

Comparison of Amisulpride vs Dexamethasone in prophylaxis of Post Operative Nausea and Vomiting in Laparoscopic Cholecystectomy: a Randomized controlled study - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104454
Enrollment
324
Registered
2026-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: K811- Chronic cholecystitis

Interventions

Intervention1: Amisulpride: Group A: Single dose Amisulpride 5 mg intravenously, diluted in 5ml given over 1 min at induction of General Anaesthesia. Control Intervention1: Dexamethasone: Group D: Sin

Sponsors

Sir Sunderlal Hospital, IMS, BHU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age range 18 to 60 years. ASA I or II. Patient s written informed consent. Patients with three or more Apfel risk factors for Postoperative Nausea and Vomiting. Patients scheduled for elective Laparoscopic Cholecystectomy Surgery.

Exclusion criteria

Exclusion criteria: Pregnancy. Lactation. Renal impairment. History of allergic reaction to Amisulpride or Dexamethasone. Refusal to take part in the study. Known use of Steroid use. Patients with dysrhythmia.

Design outcomes

Primary

MeasureTime frame
To Compare the Complete Response Rate between patients receiving amisulpride 5mg and those receiving Dexamethasone 8mg.Timepoint: The participants will be watched for symptoms like nausea and/vomiting Postoperatively at 0(baseline),1,2,3,4,6,12,24 hrs

Secondary

MeasureTime frame
To compare the Time to the first dose of rescue anti-emetic. To Compare the total rescue antiemetic requirement in 24 hours.Timepoint: 24 hours

Countries

India

Contacts

Public ContactDr Malay Bhanja

INSTITUTE OF MEDICAL SCIENCE, BHU

minearvind@gmail.com9717966333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026