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Comparison of intravenous amisulpride versus ondansetron for prevention of postoperative nausea and vomiting

Anti-emetic effects of intravenous administration of amisulpride vs ondansetron for postoperative nausea and vomiting a randomized controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109378
Enrollment
80
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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 5 mg, administered as a single dose preoperatively (3-5 minutes before induction of general anaesthesia) via IV route, with total duration limited t

Sponsors

Nikki Jain
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years Either gender ASA physical status I and II Patients undergoing surgery under general anaesthesia Duration of surgery more than or equal to 1 hour Patients with at least one Apfel risk factor: Female gender Non-smoker History of PONV or motion sickness Expected postoperative opioid use Patients willing to participate and provide written informed consent

Exclusion criteria

Exclusion criteria: ASA physical status III and above Patients undergoing: Cardiac surgery Intrathoracic surgery CNS surgery Transplant surgery Pregnant patients Patients requiring postoperative ventilation Presence of nasogastric tube in situ History of Parkinson s disease Vestibular disorders Epilepsy Alcohol abuse Known cardiac arrhythmias Renal or hepatic disease Morbid obesity Known hypersensitivity or allergy to study drugs Use of antiemetics, steroids, propofol infusion, or dexmedetomidine within 24 hours pre or post surgery Patients undergoing emergency surgery

Design outcomes

Primary

MeasureTime frame
Complete response defined as no episodes of emesis (vomiting or retching) and no use of rescue antiemeticTimepoint: Complete response defined as no episodes of emesis (vomiting or retching) and no use of rescue antiemetic at 0,2,6,12 and 24 hours postoperatively.—

Secondary

MeasureTime frame
Incidence & severity of nausea, vomiting, use of rescue antiemetic, & adverse effectsTimepoint: Incidence & severity of nausea, vomiting, use of rescue antiemetic, & adverse effects at 0,2,6,8,12 & 24 hours postoperatively—

Countries

India

Contacts

Public ContactDr Nikki Sunil Jain

Smt.Bhikhiben Kanjibhai Shah Medical Institute and Research Center

drtejash24@gmail.com9428825723

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026