Impact of Cannabis Use During Third Molar Surgery

Обзор

This study is for people scheduled to have their wisdom teeth (third molars) removed and are going to receive drug through an IV to put them to sleep. The researchers are studying two groups: one group of people who report using recreational marijuana/THC/cannabis and another group who report not using it. They want to look at how both users and non-users do during the tooth removal.

Подробное описание

When the researchers look at how both users and non-users do during the tooth removal, they will look at things like: how much medicine you need to be put to sleep, your body's vital signs like your number of heart beats, your blood pressure, and how many time you breathe during a minute.

Researchers will ask you questions about your health. If you report using marijuana/THC/cannabis, a small hair sample (about 1 or 2 inches) or fingernail (about the thickness of two credit cards from all 10 fingers) will be taken before tooth removal to check the amount of marijuana/THC/cannabis in your body. These will be sent to a lab using a number and not your name to protect your privacy and your confidential information. Also, we may be able to use the teeth that we take out to check the levels. These teeth are usually thrown away after your tooth removal.

If you report not using marijuana/THC/cannabis, a urine sample will be collected before tooth removal for a quick test to check for marijuana/THC/cannabis. We will also have you fill out a questionnaire about your pain levels and cannabis/THC use if you use it.

Первичные конечные точки

• Midazolam administered [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration]
• Mean arterial pressure [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.]
• Heart rate [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.]
• Carbon dioxide level [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.]
• Ketamine administered [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration]
• Fentanyl administered [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration]
• Propofol administered [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration]
• Respiratory rate [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.]
• Oxygen saturation [Срок оценки: The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.]

Вторичные конечные точки (3)

• Complications [Срок оценки: From tooth removal start to end of study]
• Cannabis level [Срок оценки: From enrollment until end of the study]
• Depth of Sedation [Срок оценки: From tooth removal start to end of tooth removal]

Критерии участия

Критерии включения

• Provide a signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.
• Aged ≥ 16 years old.
• Presence at least one mandibular 3rd molar
• American Society of Anesthesiologists (ASA) physical status class I or II

Критерии исключения

• Pathology (cyst or tumor) associated with the third molar tooth;
• Health comorbidities (BMI 40 and above, and severe cardiovascular disease);
• Pregnancy or lactation
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• University of Michigan School of Dentistry/ Oral and Maxillofacial Surgery — Ann Arbor

Публикации

• Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983. PMID 12799407
• Cuttler C, Spradlin A. Measuring cannabis consumption: Psychometric properties of the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU). PLoS One. 2017 May 26;12(5):e0178194. doi: 10.1371/journal.pone.0178194. eCollection 2017. PMID 28552942
• Gangwani P, Lillian D, Dobbins J, Feng C, Vorrasi J, Kolokythas A. Is Recreational Marijuana Use Associated With Changes in the Vital Signs or Anesthetic Requirements During Intravenous Sedation? J Oral Maxillofac Surg. 2023 May;81(5):527-535. doi: 10.1016/j.joms.2023.01.007. Epub 2023 Feb 3. PMID 36746375
• Ripperger D, Atte A, Ritto F. Cannabis Users Require More Anesthetic Agents for General Anesthesia in Ambulatory Oral and Maxillofacial Surgery Procedures. J Oral Maxillofac Surg. 2023 Dec;81(12):1460-1465. doi: 10.1016/j.joms.2023.09.008. Epub 2023 Sep 14. PMID 37783364
• Gangwani P, Kolokythas A. What does the preliminary data tell us about the impact of recreational marijuana use on outpatient sedation? Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Nov;136(5):531-532. doi: 10.1016/j.oooo.2023.08.012. Epub 2023 Sep 1. No abstract available. PMID 37739914
• Bicket MC, Ladha KS, Boehnke KF, Lai Y, Gunaseelan V, Waljee JF, Englesbe M, Brummett CM. The Association of Cannabis Use After Discharge From Surgery With Opioid Consumption and Patient-reported Outcomes. Ann Surg. 2024 Mar 1;279(3):437-442. doi: 10.1097/SLA.0000000000006085. Epub 2023 Aug 28. PMID 37638417
• Liu CW, Bhatia A, Buzon-Tan A, Walker S, Ilangomaran D, Kara J, Venkatraghavan L, Prabhu AJ. Weeding Out the Problem: The Impact of Preoperative Cannabinoid Use on Pain in the Perioperative Period. Anesth Analg. 2019 Sep;129(3):874-881. doi: 10.1213/ANE.0000000000003963. PMID 31425232
• Alexander JC, Joshi GP. A review of the anesthetic implications of marijuana use. Proc (Bayl Univ Med Cent). 2019 May 21;32(3):364-371. doi: 10.1080/08998280.2019.1603034. eCollection 2019 Jul. PMID 31384188

Идентификаторы

NCT: NCT07423195 · HUM00264261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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