Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto