Comparison of two different low doses of ondansetron in combination with dexamethasone for prevention of postoperative nausea and vomiting in middle ear surgery

Randomized Double- Blind Comparison of two different low doses of ondansetron in combination with dexamethasone for prophylaxis of postoperative nausea and vomiting in middle ear surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017523

Enrollment

120

Registered

2019-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: - Health Condition 2: K929- Disease of digestive system, unspecified

Interventions

Intervention1: Group- L: Patients will receive a combination of dexamethasone 8 mg (given at the beginning of surgery) and the reduced dose of ondansetron i.e. 25 Âµg/kg (given near the end of the s

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 16-65 years of either sex, with ASA physical status I or II, undergoing middle ear surgery (tympanoplasty or mastoidectomy) under GA

Exclusion criteria

Exclusion criteria: Pregnant patients Patients who received other antiemetic medication or perioperative steroids as anti-edema therapy for facial nerve damage Patients having history of cardiac, hepatic and renal disease

Design outcomes

Primary

Measure	Time frame
PONV scoreTimepoint: In the fisrt 2 hrs, 2-6 hrs, 6-12 hrs and 12-24 hrs	—

Secondary

Measure	Time frame
HR, SBP, DBP and MAPTimepoint: Every 15 minutes in the postoperative period for first 4 hrs;Total rescue antiemetic consumptionTimepoint: at the end of 24 hrs	—

Countries

India

Contacts

Public ContactDr Geetanjali T Chilkoti

University College of Medical Sciences

sethvarun3@gmail.com9873720909

Outcome results

None listed

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