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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Postoperative Pain
Nausea
Postoperative Nausea and Vomiting
Postdischarge Nausea and Vomiting

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00514878
H54427-30684

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

2,000 participants in 1 patient group

1
Description:
Adult same-day outpatients scheduled for general anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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