Clinical trial NCT02115529: Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet
Official title: A Randomized Controlled Trial of Cesamet(R) (Nabilone) for the Prevention of Postoperative Nausea and Vomiting in Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: See above

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative nausea and/or vomiting
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Secondary outcomes:
measure: Number of antiemetic rescue medications given postoperatively.
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Other outcomes:
measure: Standardized score of nausea and/or vomiting severity if PONV occurs.
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
measure: Pain score during the immediate post-operative period.
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
measure: Use of intraoperative and postoperative opioids
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
measure: Rates of known side effects.
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
measure: Time to discharge from the PACU.
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
measure: Rates of admission due to PONV
timeFrame: Prior to discharge from postanesthesia care unit, an expected average of two hours
measure: Antiemetics given prophylactically by the anesthesiologist.
timeFrame: Until discharge from postanesthesia care unit, an expected average of two hours
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
affiliation: St Michael's Hospital, University of Toronto
name: Aaron P Hong, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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