Perioperative Prospective Follow Up Of Cannabis Consumers and Discrepancy Use
Perioperative Prospective Follow Up Of Cannabis Consumers
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
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Jerusalem、イスラエル、9210141
- Hadassah Medical Center
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Study cohort: patients undergoing elective surgery who use cannabis.
Control cohort: patients undergoing elective surgery who do not regularly use cannabis.
|
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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
discrepancy percentage between reported cannabis users and actual cannabis usage among patients undergoing elective surgery.
時間枠:up to 7 days
|
up to 7 days
|
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Use of Cannabis
時間枠:up to 7 days postopertively
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Doasge Use of Cannabis
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up to 7 days postopertively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain levels during surgery as assesed using VAS
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Elyad Davidson, MD、Hadassah medical center/ Hebrew univeristy
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0001-25-HMO
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。