NCT02635828

Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

Studying the Effectiveness of Triple Therapy With Palonosetron, Dexamethasone and Promethazine for Prevention of Post Operative Nausea and Vomiting in High Risk Patients Undergoing Neurological Surgery and General Anesthesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.

Detailed description

At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron 0.075 mg IV	At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
DRUG	Dexamethasone 10 mg IV	At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
DRUG	Promethazine 25 mg IV	At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-05-01
• Completion: 2011-10-01
• First posted: 2015-12-21
• Last updated: 2017-05-05
• Results posted: 2017-05-05