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A study comparing Amisulpride–Ondansetron and Dexamethasone–Ondansetron to prevent nausea and vomiting after ear surgery

Efficacy of combination of Amisulpride-Ondansetron Vs. Dexamethasone-Ondansetron to prevent post operative nausea vomiting in middle ear surgeries-A randomized controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096267
Enrollment
80
Registered
2025-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: H65-H75- Diseases of middle ear and mastoid Health Condition 2: H669- Otitis media, unspecified

Interventions

Intervention1: Amisulpride: To prevent post operative episodes of nausea and vomiting in middle ear surgeries for a period of 24 hours Control Intervention1: Dexamethasone-Ondansetron: To prevent post

Sponsors

Dr Renita Anil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex and belonging to ASA I and II category, undergoing middle ear surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: Patients who are pregnant,lactating,already on anti-emetics, history of psychiatric illness, central nervous system disorders, history of motion sickness, allergic to study drug

Design outcomes

Primary

MeasureTime frame
To compare incidence and severity of PONV in middle ear surgeries between the two drugs. Timepoint: 0,15min,30min,1 hr, 2hr,4 hr, 6 hr, 12hr, 18hr, 24hr—

Secondary

MeasureTime frame
1.Rescue anti-emetics used 2. Number of doses of rescue anti-emetics required 3. To analyse side effects of Amisulpride 4. Analgesia (Numerical Rating Scale) 5. Patient satisfaction (Discharge from PACU) Timepoint: 0,15min,30min,1 hr, 2hr,4 hr, 6 hr, 12hr, 18hr, 24hr—

Countries

India

Contacts

Public ContactDr Renita Anil

St. Johns Medical college Hospital, Bangalore

drmanjula95@yahoo.com9449059395

Outcome results

None listed

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