Skip to content

Comparison of palanosetron and dexamethasone with ondansetron and dexamethasone for prevention of nausea and vomiting after operation in cancer patients receiving opioid based pain relief medicine

Comparison of Palanosetron and Dexamethasone with Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting in post chemotherapy patients undergoing ovarian cancer surgery receiving opioid based intravenous patient controlled analgesia

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/09/006223
Enrollment
150
Registered
2015-09-29
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: null- Cancer patients posted for ovarian cancer surgery

Interventions

Intervention1: Palonosetron and dexamethasone: Palonosetron (0.075 mg) and dexamethasone (4mg) will be given in operation theatre at the time of wound closer and there after placebo drug will be given

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18-70 years old female patients, American Society of Anaesthesiologist class I and II, Post chemotherapy patients undergoing open ovarian cancer surgery and requiring opioid based patient controlled analgesia

Exclusion criteria

Exclusion criteria: 1. American Society of Anaesthesiologist class III and above, 2. Smokers 3. Cognitive impairment or an active psychiatric condition 4. Patients with known liver and kidney diseases, 5. History of a palanosetron/ ondansetron/ dexamethasone or fentanyl allergy 6. Use of corticosteroids, psychoactive drugs or any other medication with known emetic or antiemetic effect within 24 hrs prior to surgery 7. History of opioid abuse. Extended Exclusion Criteri 1. Patients who will be shifted to intensive care unit on endotracheal tube for post operative mechanical ventilation

Design outcomes

Secondary

MeasureTime frame
Comparison ofintensities of nausea, pain, cumulative dose of opioid, rescue analgesics and antiemetic requirements, discontinuation of opioid ahead of time, and adverse eventsTimepoint: Every half an hour for first 2 hours and after that at intervals of 2 to 6, 6 to 24, 24 to 48 hours postoperatively.

Primary

MeasureTime frame
The overall incidence of Post Operative Nausea and Vomiting between the Ondasetron with dexamethasone and Palonosetron with dexamathasone groups.Timepoint: Every half an hour for first 2 hours and after that at intervals of 2 to 6, 6 to 24, 24 to 48 hours postoperatively.

Countries

India

Contacts

Public ContactDr Amit Kumar

Tata Memorial Hospital, Parel, Mumbai (India)

amit2007kr@gmail.com09869158689

Outcome results

None listed

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