Cannabis Use on Sedation for Oral Surgery Procedures

Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures

The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.

Study Overview

• Status: Withdrawn
• Conditions: Cannabis Use
• Intervention / Treatment: Drug: Sedation with Midazolam, Fentanyl, and Propofol; Procedure: Extraction of teeth

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients older than 18 years of age
• Class I or II according to the American Society of Anesthesiology (ASA)
• Need for dental extractions
• Extraction procedures with similar level of complexity

Exclusion Criteria:

• Surgical time lesser than 10 or greater than 30 minutes
• ASA status of III or greater
• BMI greater than 30 k/m2
• Pregnancy
• Use of anti-depressants, sedatives, or other mood-altering medications
• History of illicit substance abuse, alcoholism, or chronic opioid use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-users; Patients that don't use cannabis and will be submitted to sedation.	Drug: Sedation with Midazolam, Fentanyl, and Propofol; Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol; Other Names: Sedation; Procedure: Extraction of teeth; The necessary teeth will be extracted; Other Names: Surgical procedure
Experimental: Users that will stop use 72h before the procedure; Patients that use cannabis and will stop using 72 hours before sedation.	Drug: Sedation with Midazolam, Fentanyl, and Propofol; Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol; Other Names: Sedation; Procedure: Extraction of teeth; The necessary teeth will be extracted; Other Names: Surgical procedure
Experimental: Users that will stop use 12h before the procedure; Patients that use cannabis and will stop using 12 hours before sedation.	Drug: Sedation with Midazolam, Fentanyl, and Propofol; Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol; Other Names: Sedation; Procedure: Extraction of teeth; The necessary teeth will be extracted; Other Names: Surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol dose in milligrams	Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate in beats per minute	Compare how the heart rate behave during the procedure in each group	During the procedure
Blood pressure in millimeters of mercury	Compare how the blood pressure behave during the procedure in each group	During the procedure
Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale	Compare the difference in sedation quality during the procedure in each group	During the procedure

Collaborators and Investigators

• Sponsor: University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Benzazepines; Benzodiazepines; Midazolam; Propofol; Fentanyl; Surgical Procedures, Operative
• Other Study ID Numbers: 15416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No