Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

NCT ID: NCT00514878

Last Updated: 2009-11-02

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

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-11-30

Brief Summary

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The primary purpose of this prospective cohort study is to develop a simplified risk model for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US that will allow clinicians to identify those patients who would benefit from prophylactic antiemetic strategies.

Detailed Description

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Conditions

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Nausea Postoperative Nausea and Vomiting Postdischarge Nausea and Vomiting Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Adult same-day outpatients scheduled for general anesthesia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* scheduled for an elective outpatient surgical procedure
* understands the nature and purpose of this survey and has signed an informed consent form
* willing and able to complete daily components of the Patient Diary from the day of surgery until the end of the 48 hour assessment
* undergoing general anesthesia requiring a tracheal tube or laryngeal mask airway

Exclusion Criteria

* planned inpatient surgery
* inability to communicate in English
* regional anesthesia alone without general anesthesia, as PONV in this setting is known to be significantly lower \[18, 19\]
* persistent or recurrent nausea and/or vomiting before anesthesia due to other etiologies, unless clearly related only to the anxiety due to impending surgery
* minors (\< 18 years of age)
* current pregnancy by self-report (potentially confounding for etiology of nausea)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California

Principal Investigators

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Christian C Apfel, MD, PhD

Role: STUDY_DIRECTOR

Perioperative Clinical Research Core, University of California San Francisco

Locations

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Perioperative Clinical Research Core, University of California

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H54427-30684

Identifier Type: -

Identifier Source: org_study_id

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