- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07582445
Perioperative Prospective Follow Up Of Cannabis Consumers and Discrepancy Use
Perioperative Prospective Follow Up Of Cannabis Consumers
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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-
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Jerusalem, Israel, 9210141
- Hadassah Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
discrepancy percentage between reported cannabis users and actual cannabis usage among patients undergoing elective surgery.
Tidsramme: up to 7 days
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up to 7 days
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Use of Cannabis
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain levels during surgery as assesed using VAS
Tidsramme: up to 7 days
|
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Elyad Davidson, MD, Hadassah medical center/ Hebrew univeristy
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0001-25-HMO
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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