Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

Postoperative Nausea and Vomiting Clinical Trial

— PONV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357693
• Other study ID #: CEP 280/12
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2015
• Last updated: August 24, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• high risk patients for nausea and vomiting

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Brazil	Angela Maria Sousa	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nausea and vomiting in postoperative period		24 hours	No