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Comparison of two doses of Amisulpride for prevention of postoperative nausea and vomiting in cardiac surgery patients

Antiemetic efficacy of prophylactic amisulpride 5 mg versus amisulpride 10 mg in patients undergoing cardiac surgery under cardiopulmonary bypass machine: A randomized double-blinded, controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100121
Enrollment
140
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: I089- Rheumatic multiple valve disease,unspecified

Interventions

Intervention1: Amisulpiride 5 mg given intravenously (total volume 2 ml): All patients will be shifted to CTVS ICU and put on elective ventilation, Amisulpiride 5 mg given intravenously 30 minutes bef

Sponsors

Sir Sunderlal Hospital, IMS, BHU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA PS II and III 2) scheduled to undergo elective valvular heart repair under cardiopulmonary bypass machine

Exclusion criteria

Exclusion criteria: 1) Known allergy/hypersensitivity to the drug used in the study 2) patients with ventricular arrhythmias 3) patients with preoperative cardiopulmonary resuscitation 4) preoperative mechanical ventilation or dialysis 5) patients who underwent surgical reexploration

Design outcomes

Primary

MeasureTime frame
Comparison of antiemetic efficacy of amisulpride 5 mg with that of amisulpride 10 mg in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing cardiac surgery under cardio-pulmonary bypass machineTimepoint: Symptoms of PONV at 0 (time of tracheal extubation),6,12,18,24,30,36,42,48 hours—

Secondary

MeasureTime frame
1) requirement of rescue antiemetic 2) effect of amisulpride on QT interval 3) any other adverse event due to amisulprideTimepoint: Symptoms of PONV at 0 (time of tracheal extubation),6,12,18,24,30,36,42,48 hours—

Countries

India

Contacts

Public ContactDr Sanjeev Kumar

IMS BHU

dr.sanjeevkumarkem@gmail.com09650063508

Outcome results

None listed

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