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

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ClinicalTrials.gov Identifier: NCT00514878
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : November 2, 2009
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Nausea Postoperative Nausea and Vomiting Postdischarge Nausea and Vomiting Postoperative Pain

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)
Study Start Date : August 2007
Primary Completion Date : August 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Adult same-day outpatients scheduled for general anesthesia

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients scheduled for elective outpatient surgery

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514878

United States, California
Perioperative Clinical Research Core, University of California
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Merck Sharp & Dohme Corp.
Study Director: Christian C Apfel, MD, PhD Perioperative Clinical Research Core, University of California San Francisco
More Information

Responsible Party: Christian C. Apfel, MD, PhD, University of California
ClinicalTrials.gov Identifier: NCT00514878     History of Changes
Other Study ID Numbers: H54427-30684
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: December 2008

Keywords provided by University of California, San Francisco:
postoperative nausea and vomiting
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Nausea and Vomiting
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive