NCT02115529

Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Nabilone	Nabilone (0.5 mg) or placebo given preoperatively
DRUG	Placebo	Placebo Comparator: identical capsule containing placebo (single dose) given preoperatively

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-01-01
• Completion: 2015-11-01
• First posted: 2014-04-16
• Last updated: 2015-12-03

Locations

1 site across 1 country: Canada