Nabilone
Nabilone (0.5 mg) or placebo given preoperatively
CesametLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2015-12-03
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
See above
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Nabilone (0.5 mg) or placebo given preoperatively
CesametPlacebo Comparator: identical capsule containing placebo (single dose) given preoperatively
Eligibility
primary outcomes
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
secondary outcomes
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
other outcomes
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
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).
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Time frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
Time frame: Until discharge from postanesthesia care unit, an expected average of two hours
Publications
No exact PMID-linked public article is currently readable locally.