- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02115529
Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet (Cesamet)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Nabilone (0.5 mg) or placebo given preoperatively
Other Names:
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Placebo Comparator: Placebo
identical capsule containing placebo (single dose) given preoperatively
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Placebo Comparator: identical capsule containing placebo (single dose) given preoperatively
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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
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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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
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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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
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Prior to discharge from postanesthesia care unit, an expected average of two hours
|
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Pain score during the immediate post-operative period.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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Use of intraoperative and postoperative opioids
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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Rates of known side effects.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
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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).
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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Time to discharge from the PACU.
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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Rates of admission due to PONV
Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours
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Prior to discharge from postanesthesia care unit, an expected average of two hours
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Antiemetics given prophylactically by the anesthesiologist.
Time Frame: Until discharge from postanesthesia care unit, an expected average of two hours
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Until discharge from postanesthesia care unit, an expected average of two hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aaron P Hong, MD, FRCPC, St Michael's Hospital, University of Toronto
Publications and helpful links
General Publications
- Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
- Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x.
- Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
- Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. doi: 10.1007/BF03018236.
- Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.
- Gan TJ. Postoperative nausea and vomiting--can it be eliminated? JAMA. 2002 Mar 13;287(10):1233-6. doi: 10.1001/jama.287.10.1233. No abstract available.
- Weinstein RS. Glucocorticoid-induced osteonecrosis. Endocrine. 2012 Apr;41(2):183-90. doi: 10.1007/s12020-011-9580-0. Epub 2011 Dec 15.
- Pertwee RG. Receptors and channels targeted by synthetic cannabinoid receptor agonists and antagonists. Curr Med Chem. 2010;17(14):1360-81. doi: 10.2174/092986710790980050.
- Ware MA, Daeninck P, Maida V. A review of nabilone in the treatment of chemotherapy-induced nausea and vomiting. Ther Clin Risk Manag. 2008 Feb;4(1):99-107. doi: 10.2147/tcrm.s1132.
- Hsu ES. A review of granisetron, 5-hydroxytryptamine3 receptor antagonists, and other antiemetics. Am J Ther. 2010 Sep-Oct;17(5):476-86. doi: 10.1097/MJT.0b013e3181ea7821.
- Lewis IH, Campbell DN, Barrowcliffe MP. Effect of nabilone on nausea and vomiting after total abdominal hysterectomy. Br J Anaesth. 1994 Aug;73(2):244-6. doi: 10.1093/bja/73.2.244.
- Bremner WG, Kumar CM. Delayed surgical emphysema, pneumomediastinum and bilateral pneumothoraces after postoperative vomiting. Br J Anaesth. 1993 Aug;71(2):296-7. doi: 10.1093/bja/71.2.296.
- Product monograph, Nabilone (Nabilone), submission control no: 124406, Valeant Canada Limitée/Limited, March 17, 2009
- Levin DN, Dulberg Z, Chan AW, Hare GM, Mazer CD, Hong A. A randomized-controlled trial of nabilone for the prevention of acute postoperative nausea and vomiting in elective surgery. Can J Anaesth. 2017 Apr;64(4):385-395. doi: 10.1007/s12630-017-0814-3. Epub 2017 Feb 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Nabilone
Other Study ID Numbers
- 13-242
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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