NauseaApfel-PDNVNCT00514878
Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)
An observational study of Nausea and Postoperative Nausea and Vomiting, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Postoperative Nausea and Vomiting, Postdischarge Nausea and Vomiting
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective outpatient surgery
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Perioperative Clinical Research Core, University of California
San Francisco, California, 94115
About this study
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.
- Conditions
- Nausea, Postoperative Nausea and Vomiting, Postdischarge Nausea and Vomiting, Postoperative Pain
- Keywords
- nausea, postoperative nausea and vomiting, postoperative pain
- Medical subject headings
- Nausea, Postoperative Nausea and Vomiting, Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adult same-day outpatients scheduled for general anesthesia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Christian C Apfel, MD, PhD, Study director, Perioperative Clinical Research Core, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514878
- Sponsor's protocol ID
- H54427-30684
- Acronym
- Apfel-PDNV
- Status last verified
- Dec 2008
- First submitted
- 8 Aug 2007
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)
- ClinicalTrials.gov ID
- NCT00514878
- Acronym / sponsor ID
- Apfel-PDNV / H54427-30684
- Conditions
- Nausea, Postoperative Nausea and Vomiting, Postdischarge Nausea and Vomiting, Postoperative Pain
- Keywords
- nausea, postoperative nausea and vomiting, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adult same-day outpatients scheduled for general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective outpatient surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian C Apfel, MD, PhD study director
Perioperative Clinical Research Core, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Postoperative Nausea and Vomiting, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2009.