NCT02357693

Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

Detailed description

High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Aprepitant	Aprepitant or placebo will be administered to the patient before surgery

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-02-06
• Last updated: 2015-08-25

Locations

1 site across 1 country: Brazil