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Prevention of Postoperative Nausea and Vomiting in Surgical Patients
This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, April 2009
First Received: September 19, 2008   Last Updated: April 24, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: 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

MedlinePlus related topics: Nausea and Vomiting Surgery
Drug Information available for: Ondansetron hydrochloride Ondansetron Tetrahydrocannabinol
U.S. FDA Resources
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Postoperative nausea [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

Detailed Description:

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

  1. Reduction of postoperative and postdischarge nausea and vomiting in ambulatory surgery patients.
  2. Reduce rate of hospital admissions and length of inpatient stay after outpatient surgery.
  3. 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 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:   No
Criteria

Inclusion Criteria:

  1. The patients undergoing outpatient operations for intra-abdominal or abdominal wall procedures (e.g. hernias) under general anesthesia.
  2. A high-risk for PONV based on the Koivuranta risk scoring system, with inclusion of patients having a risk score of 2 or more than 2.
  3. Ability to give informed consent. 4. Veteran eligible for treatment.

Exclusion Criteria:

  • Patients <18 years old
  • Patients with a history of hypersensitivity to cannabinoids or sesame oil
  • Patients with psychiatric disorders (including substance abuse)
  • Patients on psychoactive drugs
  • Pregnant women
  • Patients with prolonged QT intervals on EKG.
  • Patients enrolled in another clinical trial at the time of randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757822

Contacts
Contact: Alison A Acott (501) 257-6526 alison.acott@va.gov
Contact: Lawrence T Kim, MD (501) 257-6850 lawrence.kim@va.gov

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
Investigators
Principal Investigator: Lawrence T. Kim, MD Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
  More Information

No publications provided

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

Study placed in the following topic categories:
Neurotransmitter Agents
Postoperative Nausea and Vomiting
Tranquilizing Agents
Vomiting
Signs and Symptoms, Digestive
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Serotonin
Tetrahydrocannabinol
Signs and Symptoms
Postoperative Complications
Analgesics, Non-Narcotic
Antipruritics
Anti-Anxiety Agents
Nausea
Ondansetron
Analgesics
Peripheral Nervous System Agents

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009