Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: August 2015

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.

Interventions

  • Drug: Aprepitant
    • Aprepitant or placebo will be administered to the patient before surgery

Arms, Groups and Cohorts

  • Experimental: aprepitant
    • aprepitant 80 mg one hour before surgery
  • Placebo Comparator: placebo
    • oral placebo one hour before surgery

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of nausea and vomiting in postoperative period
    • Time Frame: 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • high risk patients for nausea and vomiting Exclusion Criteria:

  • cardiovascular disease, or hypersensibility to any of the drugs involved in the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto do Cancer do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hazem a Ashmawi, phD, Study Director, University of Sao Paulo

Citations Reporting on Results

Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.