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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Incidence of nausea and vomiting in postoperative period
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •high risk patients for nausea and vomiting
Exclusion Criteria
- •cardiovascular disease, or hypersensibility to any of the drugs involved in the study
Arms & Interventions
aprepitant
aprepitant 80 mg one hour before surgery
Intervention: Aprepitant (Drug)
placebo
oral placebo one hour before surgery
Intervention: Aprepitant (Drug)
Outcomes
Primary Outcomes
Incidence of nausea and vomiting in postoperative period
Time Frame: 24 hours
Secondary Outcomes
No secondary outcomes reported