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- Klinische proef NCT07582445
Perioperative Prospective Follow Up Of Cannabis Consumers and Discrepancy Use
Perioperative Prospective Follow Up Of Cannabis Consumers
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Following surgery, participants will be asked to complete questions postoperatively up to 7 days. These follow-ups will gather information on any changes in cannabis use as well as symptoms such as pain intensity, nausea, sleep quality, and use of rescue medications.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Jerusalem, Israël, 9210141
- Hadassah Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
The study population will consist of patients scheduled to undergo elective surgery.
This will include individuals who regularly use cannabis, as well as a matched control cohort with similar demographics who do not use cannabis.
Beschrijving
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:
None
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Study cohort: patients undergoing elective surgery who use cannabis.
Control cohort: patients undergoing elective surgery who do not regularly use cannabis.
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urine sample
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control group
Patients undergoing elective surgery who do not use cannabis regularly
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urine sample
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
discrepancy percentage between reported cannabis users and actual cannabis usage among patients undergoing elective surgery.
Tijdsspanne: up to 7 days
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up to 7 days
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Use of Cannabis
Tijdsspanne: up to 7 days postopertively
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Doasge Use of Cannabis
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up to 7 days postopertively
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain levels during surgery as assesed using VAS
Tijdsspanne: up to 7 days
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We aim to assess whether pain levels during surgery are affected by cannabis use of the VAS questionaire
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up to 7 days
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elyad Davidson, MD, Hadassah medical center/ Hebrew univeristy
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0001-25-HMO
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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