Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients

Completed · Not applicable

Conditions studied: Postoperative Nausea and Vomiting

In brief

This study will compare two different drug regimens (oral dronabinol versus intravenous ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).

Key facts

Study ID

NCT00757822

Run by

VA Office of Research and Development

People needed

216

Starts

2009-12-01

Expected to finish

2015-04-01

Last updated by the study team

2016-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The patients undergoing outpatient operations for intra-abdominal or abdominal wall procedures (e.g. hernias) under general anesthesia.
• Patients that are at increased risk for PONV based on the Koivuranta risk scoring system, with inclusion of patients having a Koivuranta risk score (K score) of 2 or more.
• Ability to give informed consent.
• Veteran eligible for treatment.

You may not qualify if…

• Patients <18 years old
• Patients with a history of hypersensitivity to cannabinoids or sesame oil --Patients with current substance abuse.
• Substance abuse will be identified meeting one or both of the following criteria:
• a) Review the participant's medical chart to identify inpatient, residential, or outpatient treatment for alcohol or drug dependence as recorded in the Veterans Health Administration Computerized Patient Record system (CPRS) within the preceding six months.
• OR
• b) Patient report. Exclude patients who report current marijuana or cocaine use within the past 30 days.
• If a drug screen is clinically indicated and is positive the patient will NOT be entered into the study.
• Patients taking medications known to have significant drug-drug interactions with the prescribed drug and study drugs, Dronabinol and Ondansetron, will be reviewed in Micromedex. Micromedex is a medication database used by Central Arkansas Veterans Healthcare System (CAVHS). If the drug could have a drug-drug interaction with either dronabinol or ondansetron the patients will NOT be entered into the study. If a drug is confirmed via Micromedex not to have a drug-drug interaction, the patient will be eligible for study participation.
• Pregnant women
• Patients with prolonged QTC intervals on electrocardiogram (EKG).
• Patients enrolled in another clinical trial at the time of randomization.
• Inability to adhere to study protocol

Where it is running

• Central Arkansas Veterans Healthcare System-John L McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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