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Comparing Low and High Doses of Amisulpride to Prevent Nausea and Vomiting in Ear Surgery

To Compare Safety And Efficacy Of Low Dose And High Dose Of Intravenous Amisulpride In Prevention Of Nausea And Vomiting In Middle Ear Surgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075431
Enrollment
90
Registered
2024-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: Injection Amisulpride: 5mg IV route 30 mins before extubation Control Intervention1: Injection Amisulpride: 10 mg IV Route 30 mins before extubation

Sponsors

Teerthanker Mahaveer Medical College and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient posted for Elective Middle Ear Surgeries Patient giving written and informed consent American Society of Anesthesiologist (ASA) grade I-II[7] Age group of 18-65 years old Apfel Score = 2

Exclusion criteria

Exclusion criteria: Patient on any Psychotropic drug smokers Pregnant Females

Design outcomes

Primary

MeasureTime frame
To note occurrence of Intraoperative Nausea and Vomiting To compare severity of Nausea Vomiting for 24 hoursTimepoint: Baseline( At time of Extubation) 15 mins 30 mins 45 mins 1 hour 2 hours 3 hours 4 hours 8 hours 12 hours 24 hours—

Secondary

MeasureTime frame
To compare the time for onset of first episode of Nausea Vomiting To compare the efficacy of intravenous amisulpride by noting the Verbal Rating Score (VRS) To compare total rescue medication given To record any complicationsTimepoint: Baseline( At time of Extubation) 15 mins 30 mins 45 mins 1 hour 2 hours 3 hours 4 hours 8 hours 12 hours 24 hours—

Countries

India

Contacts

Public ContactDr Pallavi Ahluwalia

Teerthanker Mahaveer Medical College

pallaviahluwalia22@gmail.com8218628850

Outcome results

None listed

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