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

NCT00757822 | Completed Results DMC

• 2 other identifiers: CLIN-008-08S0167_2008I
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two different drug regimens (oral dronabinol versus intravenous ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (3)

• Incidence of Postoperative Nausea and Vomiting

  The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.

  Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)

• Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale

  VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting. VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU.

  Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit

• Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery

  Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.

  24-48 hrs post surgery

Secondary Outcomes (5)

• Post-Operative Care Unit Length of Stay (Min)

  Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)

• Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure

  Post-operative Day of Surgery (DOS)

• Post-operative Antiemetic Use

  End of surgery to 48 hr post surgery

• Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting

  Post operative follow up interviews 24 hrs to 6 wks

• Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication

  Post-operative follow-up interviews 24 hr to 6 weeks post surgery

Study Arms (2)

Arm 1

EXPERIMENTAL

dronabinol

Drug: Dronabinol

Arm 2

ACTIVE COMPARATOR

ondansetron

Drug: Ondansetron

Interventions

Dronabinol DRUG

Dronabinol (5mg) will be administered orally (p.o.) 20-60 min pre-operatively.

Also known as: Marinol

Arm 1

Ondansetron DRUG

Ondansetron (4mg) will be administered intravenously (iv) intraoperatively in those patients not receiving Dronabinol.

Also known as: Zofran

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients undergoing outpatient operations for intra-abdominal or abdominal wall procedures (e.g. hernias) under general anesthesia.
• Ability to give informed consent.
• Veteran eligible for treatment.

You may not qualify if:

• 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 the participant's medical chart to identify inpatient, residential, or outpatient treatment for alcohol or drug dependence as recorded in the Veterans Health Administration Computerized Patient Record system (CPRS) within the preceding six months.
• 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 Central Arkansas Veterans Healthcare System (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 electrocardiogram (EKG).
• Patients enrolled in another clinical trial at the time of randomization.
• Inability to adhere to study protocol

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System-John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, 72005, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dronabinol; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dr. Muhammad Jaffar
• Organization: Central Arkansas Veterans Healthcare System

Muhammad.Jaffar@va.gov

501-688-9310

Study Officials

• Sue A Theus, PhD

  Central Arkansas Veterans Healthcare System

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 23, 2008
• Study Start: December 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2015
• Last Updated: May 13, 2016
• Results First Posted: May 13, 2016

Record last verified: 2016-04

Locations

US (1)