Prevention of Postoperative Nausea and Vomiting in Surgical Patients (PONV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00757822
First received: September 19, 2008
Last updated: May 20, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


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: December 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
dronabinol
Drug: Dronabinol
Dronabinol will be administered perioperatively.
Active Comparator: Arm 2
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 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

  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 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
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 risk score of 2 or more than 2.
  • 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 CPRS to identify inpatient, residential, or outpatient treatment for alcohol or drug dependence recorded in 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 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 EKG.
  • Patients enrolled in another clinical trial at the time of randomization.
  • Inability to adhere to study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757822

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: Muhammad Jaffar Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  More Information

No publications provided

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: May 20, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Dronabinol
Ondansetron
Analgesics
Analgesics, Non-Narcotic
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Hallucinogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014