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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00514878
First received: August 8, 2007
Last updated: October 30, 2009
Last verified: December 2008

August 8, 2007
October 30, 2009
August 2007
August 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00514878 on ClinicalTrials.gov Archive Site
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Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)
Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult patients scheduled for elective outpatient surgery

  • Nausea
  • Postoperative Nausea and Vomiting
  • Postdischarge Nausea and Vomiting
  • Postoperative Pain
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1
Adult same-day outpatients scheduled for general anesthesia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
November 2008
August 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00514878
H54427-30684
No
Christian C. Apfel, MD, PhD, University of California
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
University of California, San Francisco
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP