Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients

NCT ID: NCT00858949

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-11-30

Brief Summary

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This is an observational study with the goal of determining the costs of nausea and vomiting in ambulatory patients after surgery from the US societal perspective.

Detailed Description

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The direct cost between the end of outpatient surgery and discharge from the hospital will include costs of labors and supplies for any outpatient care, physician visits, laboratory tests, and prescribed medications, which may be used to treat operation side effects. Based on the time and motion study design, the timing of these healthcare activities will be collected. The study coordinator will observe the actual time taken for each activity for each patient. The observation period will begin after completion of the outpatient surgery. The start and end times for each activity performed will be recorded. Therefore, each activity and its duration will be concurrently recorded. We will also query patients daily to determine additional costs associated with PONV until the third postoperative morning.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post surgery monitored group

Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 18 years of age or older
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids
* Patients must provide written informed consent and have at least two of the following PONV risk factors: (1) female gender, (2) history of PONV and/or currently prone to motion sickness, (3) non smoking status.

Exclusion Criteria

* Any drug with potential antiemetic efficacy within 24 hours prior to the anesthetic procedure
* Vomiting, retching, or nausea in the 24 hours preceding anesthesia
* Body mass index \>40.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel I Sessler, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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08-415

Identifier Type: -

Identifier Source: org_study_id

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