Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00757822 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Postoperative Nausea and Vomiting in Surgical Patients |
Estimated Enrollment: | 190 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
dronabinol
|
Drug: Dronabinol
Dronabinol will be administered perioperatively.
|
2: Active Comparator
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 deacdes, 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 opiod 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 and efficacious could substantially impact on the experience and the outcome of the veteran undergoing surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patients undergoing outpatient operations for intra-abdominal or abdominal wall procedures (e.g.
hernias) under general anesthesia.
Exclusion Criteria:
Contact: Alison A Acott | (501) 257-6526 | alison.acott@va.gov |
Contact: Lawrence T Kim, MD | (501) 257-6850 | lawrence.kim@va.gov |
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 |
Responsible Party: | Department of Veterans Affairs ( Kim, Lawrence - Principal Investigator ) |
Study ID Numbers: | CLIN-008-08S |
Study First Received: | September 19, 2008 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00757822 History of Changes |
Health Authority: | United States: Federal Government |
Neurotransmitter Agents Postoperative Nausea and Vomiting Tranquilizing Agents Vomiting Signs and Symptoms, Digestive Psychotropic Drugs Central Nervous System Depressants Antiemetics Hallucinogens Antipsychotic Agents Serotonin |
Tetrahydrocannabinol Signs and Symptoms Postoperative Complications Analgesics, Non-Narcotic Antipruritics Anti-Anxiety Agents Nausea Ondansetron Analgesics Peripheral Nervous System Agents |
Neurotransmitter Agents Vomiting Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Antiemetics Signs and Symptoms Serotonin Antagonists Pathologic Processes Sensory System Agents Therapeutic Uses Antipruritics Nausea |
Ondansetron Analgesics Dermatologic Agents Postoperative Nausea and Vomiting Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Tetrahydrocannabinol Serotonin Agents Postoperative Complications Analgesics, Non-Narcotic Autonomic Agents Anti-Anxiety Agents |