Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients

Time-Motion Study of PONV Costs in Ambulatory Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post surgery monitored group; Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the costs of PONV in ambulatory patients from the US societal perspective	72 hours post op

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Daniel I Sessler, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: March 9, 2009
• First Submitted That Met QC Criteria: March 9, 2009
• First Posted (Estimate): March 10, 2009

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Observational; Postoperative nausea and vomiting; Outpatient surgery; Costs
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 08-415