Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:58 AM
Study NCT ID:
NCT07423195
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Cannabis Use During Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Midazolam administered', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration', 'description': 'Amount (mg) of midazolam administered during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The amount of these medications is registered by the timing of each administration, as well as the total amount of each medication given throughout the procedure.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.', 'description': 'Measurements of mean arterial pressure (MAP - mmHG) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.'}, {'measure': 'Heart rate', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.', 'description': 'Measurements of heart rate (HR - bpm) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.'}, {'measure': 'Carbon dioxide level', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.', 'description': 'Measurements of carbon dioxide level (CO2 - %) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.'}, {'measure': 'Ketamine administered', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration', 'description': 'Amount (mg) of ketamine administered during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The amount of these medications is registered by the timing of each administration, as well as the total amount of each medication given throughout the procedure.'}, {'measure': 'Fentanyl administered', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration', 'description': 'Amount (mg) of Fentanyl administered during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The amount of these medications is registered by the timing of each administration, as well as the total amount of each medication given throughout the procedure.'}, {'measure': 'Propofol administered', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration', 'description': 'Description: Amount (mg) of propofol administered during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The amount of these medications is registered by the timing of each administration, as well as the total amount of each medication given throughout the procedure.'}, {'measure': 'Respiratory rate', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.', 'description': 'Measurements of respiratory rate (RR - breaths per minute) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.'}, {'measure': 'Oxygen saturation', 'timeFrame': 'The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.', 'description': 'Measurements of oxygen saturation level (O2 - %) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'From tooth removal start to end of study', 'description': 'Describe and compare intraoperative complications and post-op complications between patients who regularly use cannabis and patients who do not use cannabis.'}, {'measure': 'Cannabis level', 'timeFrame': 'From enrollment until end of the study', 'description': 'Correlate the amount of cannabis detected in the hair/nails/teeth before surgery with perioperative and postoperative outcomes in patients who regularly use cannabis.'}, {'measure': 'Depth of Sedation', 'timeFrame': 'From tooth removal start to end of tooth removal', 'description': 'Compare the depth of sedation (ASA classification) measured every five minutes between patients who regularly use cannabis and those who do not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wisdom tooth', 'Cannabis use', 'Sedation and analgesia'], 'conditions': ['Cannabis Use', 'Marijuana Usage', 'Sedation and Analgesia', 'Wisdom Tooth']}, 'referencesModule': {'references': [{'pmid': '12799407', 'type': 'BACKGROUND', 'citation': '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': '28552942', 'type': 'BACKGROUND', 'citation': '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': '36746375', 'type': 'BACKGROUND', 'citation': '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': '37783364', 'type': 'BACKGROUND', 'citation': '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': '37739914', 'type': 'BACKGROUND', 'citation': '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': '37638417', 'type': 'BACKGROUND', 'citation': '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': '31425232', 'type': 'BACKGROUND', 'citation': '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': '31384188', 'type': 'BACKGROUND', 'citation': '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': '36596580', 'type': 'BACKGROUND', 'citation': 'Shah S, Schwenk ES, Sondekoppam RV, Clarke H, Zakowski M, Rzasa-Lynn RS, Yeung B, Nicholson K, Schwartz G, Hooten WM, Wallace M, Viscusi ER, Narouze S. ASRA Pain Medicine consensus guidelines on the management of the perioperative patient on cannabis and cannabinoids. Reg Anesth Pain Med. 2023 Mar;48(3):97-117. doi: 10.1136/rapm-2022-104013. Epub 2023 Jan 3.'}, {'pmid': '19022119', 'type': 'BACKGROUND', 'citation': "D'Eramo EM, Bontempi WJ, Howard JB. Anesthesia morbidity and mortality experience among Massachusetts oral and maxillofacial surgeons. J Oral Maxillofac Surg. 2008 Dec;66(12):2421-33. doi: 10.1016/j.joms.2008.06.095."}, {'pmid': '21783001', 'type': 'BACKGROUND', 'citation': 'Braidy HF, Singh P, Ziccardi VB. Safety of deep sedation in an urban oral and maxillofacial surgery training program. J Oral Maxillofac Surg. 2011 Aug;69(8):2112-9. doi: 10.1016/j.joms.2011.04.017.'}, {'pmid': '33382992', 'type': 'BACKGROUND', 'citation': 'Wiemer SJ, Nathan JM, Heggestad BT, Fillmore WJ, Viozzi CF, Van Ess JM, Arce K, Ettinger KS. Safety of Outpatient Procedural Sedation Administered by Oral and Maxillofacial Surgeons: The Mayo Clinic Experience in 17,634 Sedations (2004 to 2019). J Oral Maxillofac Surg. 2021 May;79(5):990-999. doi: 10.1016/j.joms.2020.12.002. Epub 2020 Dec 5.'}, {'pmid': '38750658', 'type': 'BACKGROUND', 'citation': 'Wiemer SJ, Mediratta JK, Triana RR, Card J, Rallis D, Rieck KL, Holmes E, Krishnan DG. What Is the Incidence of Anesthesia-Related Adverse Events in Oral and Maxillofacial Surgery Offices? A Review of 61,237 Sedation Cases From a Large Private Practice Consortium. J Oral Maxillofac Surg. 2024 Aug;82(8):895-901. doi: 10.1016/j.joms.2024.04.014. Epub 2024 Apr 25.'}], 'seeAlsoLinks': [{'url': 'https://dalspace.library.dal.ca/bitstreams/4138c891-84eb-430b-9200-90661658c693/download', 'label': 'The impact of cannabis use on procedural sedation and analgesia for third molar surgery.'}, {'url': 'https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox', 'label': 'National Institutes of Health. (n.d.). NIH Toolbox Pain Intensity Scale.'}, {'url': 'https://aaoms.org/wp-content/uploads/2024/03/office_based_anesthesia_whitepaper_1.pdf', 'label': 'AAOMS White Paper: Office Based Anesthesia'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "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.\n\nResearchers 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.\n\nIf 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is patients who are scheduled for third molar extraction surgery under IV sedation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide a signed and dated informed consent form.\n* Willing to comply with all study procedures and be available for the duration of the study.\n* Aged ≥ 16 years old.\n* Presence at least one mandibular 3rd molar\n* American Society of Anesthesiologists (ASA) physical status class I or II\n\nExclusion Criteria:\n\n* Pathology (cyst or tumor) associated with the third molar tooth;\n* Health comorbidities (BMI 40 and above, and severe cardiovascular disease);\n* Pregnancy or lactation\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study."}, 'identificationModule': {'nctId': 'NCT07423195', 'briefTitle': 'Impact of Cannabis Use During Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Impact of Cannabis Use During Third Molar Surgery', 'orgStudyIdInfo': {'id': 'HUM00264261'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'marijuana/THC/cannabis users', 'description': 'marijuana/THC/cannabis users'}, {'label': 'Non marijuana/THC/cannabis users', 'description': 'Non marijuana/THC/cannabis users'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Lay-Luskin, MPhil, CCRC', 'role': 'CONTACT', 'email': 'jalay@umich.edu', 'phone': '734-763-5963'}], 'facility': 'University of Michigan School of Dentistry/ Oral and Maxillofacial Surgery', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Jennifer A Lay-Luskin, MPhil, CCRC', 'role': 'CONTACT', 'email': 'jalay@umich.edu', 'phone': 'Oral and Maxillofacial Surgery'}, {'name': 'Bradley Blitstein, DDS', 'role': 'CONTACT', 'email': 'bjblitst@umich.edu', 'phone': '734-936-0864'}], 'overallOfficials': [{'name': 'Paulo zupelari Gonclaves, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan School of Dentistry/Oral and Maxillofacial Surgery/Hospital Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study only takes place at University of Michigan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Paulo Zupelari Goncalves Title Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery/Hospital Dentistry, School of Dentistry', 'investigatorFullName': 'Paulo Zupelari Goncalves', 'investigatorAffiliation': 'University of Michigan'}}}}