Perioperative Prospective Follow Up Of Cannabis Consumers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 600
- Locations
- 1
Study Overview
Brief Summary
This study includes a prospective non interventional study that aims to asses the prevalence of cannabis use among patients undergoing elective surgery and evaluates its impact on perioperative outcomes, including pain, opioid consumption, nausea, anxiety, and sleep disturbances. A matched control cohort will provide comparative data. Discrepancies between self-reported and objectively measured cannabis use will be assessed using blood samples and urine samples. Participants will be requested to complete preoperative and postoperative questionnaires on days 1, 2, 3, 7, and 30 to monitor cannabis use and perioperative symptoms. This study aims to clarify the perioperative effects of cannabis use and the accuracy of patient-reported consumption.
Detailed Description
This study aims to assess the proportion of cannabis users who undergo surgery. In addition, we seek to evaluate whether chronic cannabis use affects the perioperative period. Specifically, we will examine whether cannabis use around the time of surgery influences levels of pain, opioid consumption, nausea, anxiety, and sleep disturbances.
A matched control cohort with similar patient characteristics will be used for comparison.
Another key objective is to assess discrepancies between patients' self-reported cannabis use and their actual usage. This will be evaluated by comparing patient-reported data to objective measures such as blood test results and documented cannabis levels in medical records. We hypothesize that patients tend to underreport their cannabis use relative to the levels detected through clinical testing.
Following signing an informed consent, study participants will be asked to complete a preoperative questionnaire to assess their cannabis consumption habits.
Prior to anesthesia adminsatration, a 6 cc blood sample will be collected from the patient's intravenous line. This sample will be used to measure cannabis levels in the blood, allowing for a comparison between self-reported cannabis use and actual detected levels. The sample will be immediately labeled with a unique serial number in the operating room. After plasma separation via centrifugation, the sample will be frozen for later analysis using high-performance liquid chromatography (HPLC . All samples will be deidentified to external personal.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients who use cannabis and are scheduled to undergo elective surgery.
- •A matched control cohort of patients with similar demographics who are also scheduled for elective surgery.
Exclusion Criteria
- Not provided
Arms & Interventions
control group
Patients undergoing elective surgery who do not use cannabis regularly
Intervention: This study is non interventional and will only include filling in questionnaires and providing blood and urine sample (Other)
Study cohort: patients undergoing elective surgery who use cannabis.
Control cohort: patients undergoing elective surgery who do not regularly use cannabis.
Intervention: This study is non interventional and will only include filling in questionnaires and providing blood and urine sample (Other)
Investigators
Elyad Davidson
Chair of pain clinic
Hadassah Medical Organization