Development of a Predictive Model for Post-Discharge Naus... | NCT00514878

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

NCT00514878

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Nov 2, 2009Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Nausea
Postoperative Nausea and Vomiting
Postdischarge Nausea and Vomiting
Postoperative Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 8, 2007

First Posted Date

Aug 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2009

Last Update Posted Date

Nov 2, 2009Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Label	Type	Description	Intervention Names
1		Adult same-day outpatients scheduled for general anesthesia

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients scheduled for elective outpatient surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian C Apfel, MD, PhD	Perioperative Clinical Research Core, University of California San Francisco	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Perioperative Clinical Research Core, University of California		San Francisco	California	94115	United States

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D020250	Postoperative Nausea and Vomiting
D014839	Vomiting
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided