Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients

Completed

• Conditions: Postoperative Nausea and Vomiting

• Registration Number: NCT00858949
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the costs of PONV in ambulatory patients from the US societal perspective	72 hours post op

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States