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
  Purpose

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
Nausea
Postoperative Nausea and Vomiting
Postdischarge Nausea and Vomiting
Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 2000
Study Start Date: August 2007
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adult same-day outpatients scheduled for general anesthesia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients scheduled for elective outpatient surgery

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514878

Locations
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.
Investigators
Study Director: Christian C Apfel, MD, PhD Perioperative Clinical Research Core, University of California San Francisco
  More Information

No publications provided

Responsible Party: Christian C. Apfel, MD, PhD, University of California
ClinicalTrials.gov Identifier: NCT00514878     History of Changes
Other Study ID Numbers: H54427-30684
Study First Received: August 8, 2007
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nausea
Pain, Postoperative
Postoperative Nausea and Vomiting
Vomiting
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 29, 2014