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OpenTrials
Completed

NCT Number: NCT00858949

Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To determine the costs of PONV in ambulatory patients from the US societal perspective

    Time frame: 72 hours post op

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Time-Motion Study of PONV Costs in Ambulatory Surgery

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2009
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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