Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Time-Motion Study of PONV Costs in Ambulatory Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858949
• Other study ID #: 08-415
• Status: Completed
• Phase: N/A
• First received: March 9, 2009
• Last updated: July 18, 2016
• Start date: August 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the costs of PONV in ambulatory patients from the US societal perspective		72 hours post op	No