Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet (Cesamet)

December 1, 2015 updated by: Unity Health Toronto

A Randomized Controlled Trial of Cesamet(R) (Nabilone) for the Prevention of Postoperative Nausea and Vomiting in Elective Surgery

Untreated, one third of patients undergoing general anesthesia will have postoperative nausea, vomiting, or both.

Patients often rate postoperative nausea and vomiting (PONV) as worse than postoperative pain. PONV increases the risk of aspiration and has been associated with suture dehiscence, esophageal rupture, subcutaneous emphysema, and bilateral pneumothoraxes. PONV frequently delays discharge, and is the leading cause of unexpected hospital admission after planned ambulatory surgery.

Nabilone (Cesamet®) is a synthetic cannabinoid developed in the 1970s which is a potent CB1 agonist. The use of nabilone in preventing nausea and vomiting in patients receiving chemotherapy has been thoroughly investigated. Results from clinical studies demonstrated the efficacy, safety, and tolerability of Cesamet in this population. There has been success in the past translating treatments for chemotherapy-induced nausea and vomiting (ie. 5-HT receptor agonists including Ondansetron and Granisetron) to use in the perioperative environment.

Only one RCT has studied the use of nabilone for the reduction of PONV. Published in 1995, this study compared the administration of either Cesamet 2 mg or metoclopramide 10 mg given 90 minutes before the operation in patients scheduled for elective hysterectomy in 60 women. This study failed to show any significant difference between groups. There are several limitations to this study including a poorly optimized dosing regimen, a small sample size, and a comparison group lacking clinical generalizability.

This study will investigate the use Cesamet vs Placebo, in addition to the regular antiemetic treatment which patients receive at the discretion of the managing anesthesiologist, for the prevention of PONV. The study group will include patients undergoing general anesthesia for elective ambulatory surgery with at least 3 risk factors (>60% risk) for the development of PONV.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

331

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective surgery under general anesthesia with pre-anesthesia consultation prior to surgery.
  • Subjects must be able to swallow study medication;
  • At a risk of postoperative nausea and vomiting of at least 61% percent, according to a simplified risk score, based on the presence of at least three of the following risk factors: female sex, nonsmoker status, anticipated use of postoperative opioid and previous PONV or motion sickness.

Exclusion Criteria:

  • Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease
  • Patients who will not be admitted to the PACU post-operatively (patients who are immediately transferred to the ICU)
  • Known sensitivity to marijuana or other cannabinoid agents
  • Psychotic illness or depression
  • Addiction to illicit substances or alcohol
  • Non-psychotic emotional disorders.
  • Pregnant or lactating
  • Subjects who suffer from chronic nausea and/or vomiting;
  • Has had treatment with any other investigational drug within 12 weeks prior to randomization
  • Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cesamet (nabilone)
0.5 mg capsule containing Cesamet (single dose) given preoperatively
Nabilone (0.5 mg) or placebo given preoperatively
Other Names:
  • Cesamet
Placebo Comparator: Placebo
identical capsule containing placebo (single dose) given preoperatively
Placebo Comparator: identical capsule containing placebo (single dose) given preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative nausea and/or vomiting
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of antiemetic rescue medications given postoperatively.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized score of nausea and/or vomiting severity if PONV occurs.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours
Pain score during the immediate post-operative period.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours
Use of intraoperative and postoperative opioids
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours
Rates of known side effects.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Nabilone side effects include: drowsiness, vertigo, psychological high, dry mouth, depression, blurred vision, sensation disturbance, anorexia, headache, euphoria, and hallucinations (based on patient self-reporting).
Prior to discharge from postanesthesia care unit, an expected average of two hours
Time to discharge from the PACU.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours
Rates of admission due to PONV
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Prior to discharge from postanesthesia care unit, an expected average of two hours
Antiemetics given prophylactically by the anesthesiologist.
Time Frame: Until discharge from postanesthesia care unit, an expected average of two hours
Until discharge from postanesthesia care unit, an expected average of two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aaron P Hong, MD, FRCPC, St Michael's Hospital, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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