Impact of Cannabis Use During Third Molar Surgery

NCT07423195 | Recruiting

• 1 other identifier: HUM00264261
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use; Marijuana Usage; Sedation and Analgesia; Wisdom Tooth

Keywords

Wisdom tooth; Cannabis use; Sedation and analgesia

Outcome Measures

Primary Outcomes (9)

• Midazolam administered

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration

• Fentanyl administered

  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.

  The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration

• Propofol administered

  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.

  The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration

• Respiratory rate

  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.

  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

  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.

  The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.

Secondary Outcomes (3)

• Complications

  From tooth removal start to end of study

• Cannabis level

  From enrollment until end of the study

• Depth of Sedation

  From tooth removal start to end of tooth removal

Study Arms (2)

marijuana/THC/cannabis users

marijuana/THC/cannabis users

Non marijuana/THC/cannabis users

Non marijuana/THC/cannabis users

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is patients who are scheduled for third molar extraction surgery under IV sedation.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry/ Oral and Maxillofacial Surgery

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 36596580 BACKGROUND

• 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: 19022119 BACKGROUND

• 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: 21783001 BACKGROUND

• 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: 33382992 BACKGROUND

• 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.

  PMID: 38750658 BACKGROUND

Related Links

• The impact of cannabis use on procedural sedation and analgesia for third molar surgery.
• National Institutes of Health. (n.d.). NIH Toolbox Pain Intensity Scale.
• AAOMS White Paper: Office Based Anesthesia

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo zupelari Gonclaves, DDS, MS, PhD

  University of Michigan School of Dentistry/Oral and Maxillofacial Surgery/Hospital Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer A Lay-Luskin, MPhil, CCRC

CONTACT

Oral and Maxillofacial Surgery; jalay@umich.edu

Bradley Blitstein, DDS

CONTACT

734-936-0864; bjblitst@umich.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paulo Zupelari Goncalves Title Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery/Hospital Dentistry, School of Dentistry

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 20, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)