N/A
N=180
Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients
Postoperative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00757822 ↗Enrolled (actual)
180
Serious AEs
12.8%
Results posted
May 2016
Primary outcome: Primary: Incidence of Postoperative Nausea and Vomiting — 34.4; 29.8; 12.5; 7 percentage of participants — p=>0.76
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dronabinol (Drug); Ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Postoperative Nausea and Vomiting |
34.4; 29.8; 12.5; 7 | >0.76 |
| PRIMARY Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale |
59.4; 70.2; 15.6; 12.3; 7.8; 1.8 | >0.92 |
| PRIMARY Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery |
23.4; 22.8; 6.3; 3.5 | >0.55 |
| SECONDARY Post-Operative Care Unit Length of Stay (Min) |
99.5; 97.0 | =0.981 |
| SECONDARY Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure |
3; 3; 4; 3; 1; 1 | >0.90 |
| SECONDARY Post-operative Antiemetic Use |
25; 17; 3; 4 | >0.37 |
| SECONDARY Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting |
92; 89; 87; 75 | >0.75 |
| SECONDARY Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication |
80; 70; 73; 68 | >0.29 |
Summary
This study will compare two different drug regimens (oral dronabinol versus intravenous ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00757822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.