Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT02115529
First received: March 3, 2014
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Nabilone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Cesamet(R) (Nabilone) for the Prevention of Postoperative Nausea and Vomiting in Elective Surgery

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Incidence of postoperative nausea and/or vomiting [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of antiemetic rescue medications given postoperatively. [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pain score during the immediate post-operative period. [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]
  • Use of intraoperative and postoperative opioids [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]
  • Rates of known side effects. [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]
    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 to discharge from the PACU. [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]
  • Rates of admission due to PONV [ Time Frame: Prior to discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]
  • Antiemetics given prophylactically by the anesthesiologist. [ Time Frame: Until discharge from postanesthesia care unit, an expected average of two hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cesamet (nabilone)
0.5 mg capsule containing Cesamet (single dose) given preoperatively
Drug: Nabilone
Nabilone (0.5 mg) or placebo given preoperatively
Other Name: Cesamet
Placebo Comparator: Placebo
identical capsule containing placebo (single dose) given preoperatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115529

Contacts
Contact: Aaron P Hong, MD, FRCPC 416-864-5071 honga@smh.ca
Contact: David N Levin, MD 647-808-8129 dlevin3@gmail.com

Locations
Canada, Ontario
St Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Aaron P Hong, MD, FRCPC         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Aaron P Hong, MD, FRCPC St Michael's Hospital, University of Toronto
  More Information

Publications:
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02115529     History of Changes
Other Study ID Numbers: 13-242
Study First Received: March 3, 2014
Last Updated: April 14, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nabilone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014