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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00757822 |
Purpose
This study will examine two different drug regimens for prevention of post-operative nausea.
| Condition | Intervention |
|---|---|
|
Postoperative Nausea and Vomiting |
Drug: Dronabinol Drug: Ondansetron |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 190 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
dronabinol
|
Drug: Dronabinol
Dronabinol will be administered perioperatively.
|
|
Active Comparator: 2
ondansetron
|
Drug: Ondansetron
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.
Specific Objectives
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Patients with a history of hypersensitivity to cannabinoids or sesame oil
Substance abuse will be identified meeting one or both of the following criteria:
a)Review CPRS to identify inpatient, residential, or outpatient treatment for alcohol or drug dependence recorded in CPRS within the preceding six months.
OR a)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.
Contacts and Locations| United States, Arkansas | |
| Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | |
| No. Little Rock, Arkansas, United States, 72114-1706 | |
| Principal Investigator: | Lawrence T. Kim, MD | Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00757822 History of Changes |
| Other Study ID Numbers: | CLIN-008-08S, 0167_2008I |
| Study First Received: | September 19, 2008 |
| Last Updated: | January 30, 2012 |
| Health Authority: | United States: Federal Government |
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Tetrahydrocannabinol Ondansetron Hallucinogens Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antiemetics Autonomic Agents Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents |