Anesthetic Premedication With a Cannabis Extract (Cannapremed)
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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.