Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

NCT ID: NCT02357693

Last Updated: 2015-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-08-31

Brief Summary

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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

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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

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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aprepitant

aprepitant 80 mg one hour before surgery

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

Aprepitant or placebo will be administered to the patient before surgery

placebo

oral placebo one hour before surgery

Group Type PLACEBO_COMPARATOR

Aprepitant

Intervention Type DRUG

Aprepitant or placebo will be administered to the patient before surgery

Interventions

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Aprepitant

Aprepitant or placebo will be administered to the patient before surgery

Intervention Type DRUG

Other Intervention Names

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Emend

Eligibility Criteria

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Inclusion Criteria

* high risk patients for nausea and vomiting

Exclusion Criteria

* cardiovascular disease, or hypersensibility to any of the drugs involved in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hazem a Ashmawi, phD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Angela Maria Sousa

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 25220550 (View on PubMed)

Other Identifiers

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CEP 280/12

Identifier Type: -

Identifier Source: org_study_id

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