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Cannabis Use on Sedation for Oral Surgery Procedures

Sponsor
University of Oklahoma (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05873465
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
25.3
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sedation with Midazolam, Fentanyl, and Propofol
  • Procedure: Extraction of teeth
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
Anticipated Study Start Date :
May 22, 2023
Anticipated Primary Completion Date :
May 21, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Propofol dose in milligrams [During the procedure]

      Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use

    Secondary Outcome Measures

    1. Heart rate in beats per minute [During the procedure]

      Compare how the heart rate behave during the procedure in each group

    2. Blood pressure in millimeters of mercury [During the procedure]

      Compare how the blood pressure behave during the procedure in each group

    3. Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale [During the procedure]

      Compare the difference in sedation quality during the procedure in each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of Dentistry Oklahoma City Oklahoma United States 73117

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT05873465
    Other Study ID Numbers:
    • 15416
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    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
    Additional relevant MeSH terms:
    Marijuana Abuse
    Fentanyl
    Midazolam
    Propofol

    Study Results

    No Results Posted as of May 24, 2023