Anesthetic Premedication With a Cannabis Extract (Cannapremed)

NCT02283281 | Unknown Phase 2 DMC

• 1 other identifier: Cannapremed-HMO-CTIL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical evidence about the effects of cannabis in a perioperative setting or for the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute post-operative pain and nausea, at least for a selected group of patients and through an appropriate therapeutic intervention. Therefore, it seems to us pertinent to carry out an investigation in order to re-evaluate the issue of perioperative cannabis use through a sufficiently powered and controlled clinical trial. Some of cannabis effects such as sedation, bronchodilation, dryness of respiratory secretions, vein dilation, and increase of heart rater without producing hypertension, make of it an attractive option for pre-medication; while its antiemetic properties and its analgesic potential without causing respiratory depression may be profitable for the post-operative period. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. The investigators expect to obtain less sedation, milder "high", lower incidence of anxiety, tachycardia, and hyperalgesia, as compared with THC-only acute pain trials.

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Anxiety

Outcome Measures

Primary Outcomes (2)

• Postoperative pain - VAS

  Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement. Pre-operative baseline, on arrival to recovery room, after 1 h, before discharge, at 6, 12, and 24 h.

  24 hours

• Postoperative pain - PCA

  Count of patient-controlled analgesia pushes 1 hour after arrival to the recovery room, before discharge, at 6, and 12. Total dose of morphine received in 24 hours.

  24 hours

Secondary Outcomes (3)

• Postoperative nausea and vomiting (PONV) score

  24 hours

• Anxiety - VAS

  6 hours

• Cannabinoid blood levels

  24 hours

Study Arms (3)

Cannabis oil high dose

EXPERIMENTAL

Single-dose, before anesthetic induction: 21.6 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic

Drug: Tetrahydrocannabinol

Cannabis oil low dose

EXPERIMENTAL

Single-dose, before anesthetic induction: 10.8 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic.

Drug: Tetrahydrocannabinol

Control

PLACEBO COMPARATOR

Single-dose, before anesthetic induction: Dummy oromucosal spray containing alcohol vehicle without Cannabis oil .

Drug: Dummy oromucosal

Interventions

Tetrahydrocannabinol DRUG

1:1 THC to CBD standardized extract from cannabis plant

Also known as: Cannabis oil

Cannabis oil high dose; Cannabis oil low dose

Dummy oromucosal DRUG

drops containing only Olive oil vehicle without the active compound (i.e.: without Cannabis oil)

Also known as: Cannabis oil placebo

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective surgeries suitable for postoperative pain treatment with intravenous morphine patient-controlled analgesia.
• American Society of Anesthesiologist (ASA) risk I or II

You may not qualify if:

• ASA III or higher
• Cannabis use within the last 6 months
• Pregnancy
• Emergency surgeries
• Regional anesthesia
• Ischemic heart disease
• Renal failure
• History of psychosis
• Cognitive impairment or inability to answer questions

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Hasassah - Hebrew University Ein Kerem Medical Center

Jerusalem, 12000, Israel

RECRUITING

Related Publications (1)

• Laursen DR, Nejstgaard CH, Bjorkedal E, Frost AD, Hansen MR, Paludan-Muller AS, Prosenz J, Werner CP, Hrobjartsson A. Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo. Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2.

  PMID: 36877132 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Anxiety Disorders

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Elyad Davidson, M.D.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elyad Davidson

CONTACT

EDAVIDSON@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 5, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)