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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

Phase 3
Completed
Conditions
Cancer patients posted for ovarian cancer surgery
Registration Number
CTRI/2015/09/006223
Brief Summary

Postoperative nausea and vomiting (POVN) is considered one of the most unpleasant postoperative discomforts and leads to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The incidence of PONV is 30-40% in normal populations and touches a peak of 75-80% in certain high-risk groups.The use of opioid-based intravenous-patient controlled analgesia (IV-PCA) for controlling postoperative pain has become widespread. Yet while IV-PCA is effective in controlling postoperative pain, continuous administration of opioid can cause or aggravate PONV. PONV is the most common reason why patients choose to stop IV-PCA. Ondansetron is the first 5-HT3 antagonist, used alone or in combination for the prophylaxis due to its lower cost. Palonosetron is a second generation 5-HT3 antagonist with a unique chemical structure and longer half- life of 40 hours. It is found to be very effective in chemotherapy induced nausea and vomiting as well as PONV. Dexamethasone with a  5-HT3 antagonist  is an attractive combination, because ondansetron is most effective against early vomiting, whereas dexamethasone is effective against both early and late (2–24 h) nausea and vomiting, its late efficacy being pronounced.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
150
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
  • American Society of Anaesthesiologist class III and above, 2.
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The overall incidence of Post Operative Nausea and Vomiting between the Ondasetron with dexamethasone and Palonosetron with dexamathasone groups.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.
Secondary Outcome Measures
NameTimeMethod
Comparison ofintensities of nausea, pain, cumulative dose of opioid, rescue analgesics and antiemetic requirements, discontinuation of opioid ahead of time, and adverse eventsEvery half an hour for first 2 hours and after that at intervals of 2 to 6, 6 to 24, 24 to 48 hours postoperatively.

Trial Locations

Locations (1)

Tata Memorial Hospital

🇮🇳

Mumbai, MAHARASHTRA, India

Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Kailash Sharma
Principal investigator
09821161087
rashmikailashsharma@yahoo.co.in

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