- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514878
Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV) (Apfel-PDNV)
October 30, 2009 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94115
- Perioperative Clinical Research Core, University of California
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients scheduled for elective outpatient surgery
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Adult same-day outpatients scheduled for general anesthesia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Christian C Apfel, MD, PhD, Perioperative Clinical Research Core, University of California San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
August 8, 2007
First Submitted That Met QC Criteria
August 8, 2007
First Posted (Estimate)
August 10, 2007
Study Record Updates
Last Update Posted (Estimate)
November 1, 2009
Last Update Submitted That Met QC Criteria
October 30, 2009
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H54427-30684
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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