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Comparing combination of 2 different anti- emetic groups in treating the nausea & vomiting,pot- middle ear surgeries

Comparision of PALONOSETRON - DEXAMETHASONE and ONDANSETRON -DEXAMETHASONE for prevention of post- operative nausea and vomiting in middle ear surgery -A randomized clinical trial - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085593
Enrollment
64
Registered
2025-04-24
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: H95-H95- Intraoperative and postprocedural complications and disorders of ear and mastoid process, not elsewhere classified

Interventions

Intervention1: Drug intervention: Inj Metaclopramide 10mg IV is given post-operatively to treat severe nausea and vomiting Control Intervention1: Inj Ondansetron 4mg IV + Inj Dexamethasone 8 mg IV vs

Sponsors

Hospital Shri Bhausaheb Hire Government Medical College DHULE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients undergoing elective middle ear surgeries under general anaesthesia (with or without intubation) 2)Age 18-60 years 3)Male & Female 4) ASA physical status I,II

Exclusion criteria

Exclusion criteria: 1) Sensitivity to study drug 2) pregnant & lactating 3) History of use or addiction to other antiemetic drugs 4) cardiovascular/neurological/ history of psychiatric illness 5) history of motion sickness

Design outcomes

Primary

MeasureTime frame
1) to compare effectiveness of Ondansetron - dexamethasone & Palonosetron - dexamethasone in preventing nausea & vomiting in first 24 hour post surgery 2) incidence of nausea & vomiting post operatively in study population 3) severity of nausea & vomiting post- operatively in study population 4) requirement of rescue anti emeticTimepoint: 0-2 hours , 2-6 hours , 6-24 hours post-operatively

Secondary

MeasureTime frame
1) identifying peak period of PONV , rapidity & duration of action of anti- emetic combination 2) To identify, compare & study side- effects of the drugs anyTimepoint: 24 hours post-operatively

Countries

India

Contacts

Public ContactDr Hemanjali cherukuri

Shri Bhausaheb Hire Government Medical College, dhule

drsandipthorat@gmail.com9822542870

Outcome results

None listed

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