NCT02357693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

January 31, 2015

Last Update Submit

August 24, 2015

Conditions

Postoperative Nausea and Vomiting

Keywords

nausea, postoperativepostoperative nauseapostoperative vomitingvomiting, postoperative

Outcome Measures

Primary Outcomes (1)

  • Incidence of nausea and vomiting in postoperative period

    24 hours

Study Arms (2)

aprepitant

EXPERIMENTAL

aprepitant 80 mg one hour before surgery

Drug: Aprepitant

placebo

PLACEBO COMPARATOR

oral placebo one hour before surgery

Drug: Aprepitant

Interventions

AprepitantDRUG

Aprepitant or placebo will be administered to the patient before surgery

Also known as: Emend
aprepitantplacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high risk patients for nausea and vomiting

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angela Maria Sousa

São Paulo, São Paulo, 01403010, Brazil

Location

Related 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 Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.

    PMID: 25220550RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hazem a Ashmawi, phD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 6, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

BR(1)