Overview

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

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study will compare two different drug regimens (oral dronabinol versus intravenous ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
VA Office of Research and Development
Treatments:
Dronabinol
Ondansetron
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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