Prevention of Postoperative Nausea and Vomiting in Surgical Patients (PONV)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Prevention of Postoperative Nausea and Vomiting in Surgical Patients|
- Postoperative nausea [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||March 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Dronabinol will be administered perioperatively.
Active Comparator: Arm 2
Ondansetron will be administered perioperatively in those patients not receiving Dronabinol.
Research Plan Anesthesia has become remarkably safe during the past two decades, yet postoperative nausea and vomiting (PONV) continues to be a vexing problem with an unacceptably high incidence. Multiple factors including age, gender, type of surgery and anesthetic agents, perioperative opioid use and duration of anesthesia have been implicated in the cause of PONV. Several new drugs have been introduced during the last two decades to minimize PONV; however the incidence still remains significantly high, ranging from 30% during the first 24 postoperatively to 35% post discharge. Unrelenting PONV results in delayed discharge which is particularly significant after outpatient surgery. The proposed study will provide scientifically convincing evidence to support the need for a cost effective prophylaxis of PONV.
The chemoreceptor trigger zone (CTZ) functions as emetic chemoreceptor for the vomiting centers. Many antiemetic drugs acting at the level of the CTZ are responsible for vomiting in patients receiving chemotherapy and postoperative patients. Our regimen has been proven to reduce the incidence of PONV in patients receiving chemotherapy. We intend to prove that a regimen that has been utilized in patients receiving chemotherapeutic drugs will work in patients with higher incidence of PONV. We hypothesize that a regimen of low dose dronabinol preoperatively is superior in efficacy to a standard antiemetic in preventing the incidence of PONV, and thus not only improve patient satisfaction but also reduce length of stay in patients undergoing surgery that is potentially outpatient based.
- Reduction of postoperative and postdischarge nausea and vomiting in ambulatory surgery patients.
- Reduce rate of hospital admissions and length of inpatient stay after outpatient surgery.
- Improve patient satisfaction after outpatient surgery.
Procedure After informed consent, high risk surgical patients will be randomized to receive either the study drug oral dronabinol (5 mg) preoperatively and ondansetron intravenously at the end of surgery. The outcome measures will be the presence or absence of PONV, the severity and number of such episodes, the event count of rescue antiemetic use and patient satisfaction. All data will be recorded by personnel who are blinded to the drug regimen.
Relevance At the VA, 2/3 of our patients are scheduled for outpatient surgical procedure everyday. Our regimen will minimize postoperative and postdischarge nausea and vomiting, improve PACU length of stay, minimize unnecessary hospital admissions, provide patient satisfaction and cost containment. The potential for application of this inexpensive intervention to other surgeries is enormous. Reducing the incidence of PONV could have a significant impact on patient satisfaction. The intervention is very low-risk and efficacious could substantially impact on the experience and the outcome of the veteran undergoing surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757822
|United States, Arkansas|
|Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock|
|No. Little Rock, Arkansas, United States, 72114-1706|
|Principal Investigator:||Muhammad Jaffar||Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|