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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02357693
Acronym
PONV
Enrollment
90
Registered
2015-02-06
Start date
2015-02-28
Completion date
2015-08-31
Last updated
2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

nausea, postoperative, postoperative nausea, postoperative vomiting, vomiting, postoperative

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.

Interventions

DRUGAprepitant

Aprepitant or placebo will be administered to the patient before surgery

Sponsors

Instituto do Cancer do Estado de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Incidence of nausea and vomiting in postoperative period24 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026