Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Oklahoma
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Propofol dose in milligrams
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Non-users
Patients that don't use cannabis and will be submitted to sedation.
Intervention: Sedation with Midazolam, Fentanyl, and Propofol (Drug)
Non-users
Patients that don't use cannabis and will be submitted to sedation.
Intervention: Extraction of teeth (Procedure)
Users that will stop use 72h before the procedure
Patients that use cannabis and will stop using 72 hours before sedation.
Intervention: Sedation with Midazolam, Fentanyl, and Propofol (Drug)
Users that will stop use 72h before the procedure
Patients that use cannabis and will stop using 72 hours before sedation.
Intervention: Extraction of teeth (Procedure)
Users that will stop use 12h before the procedure
Patients that use cannabis and will stop using 12 hours before sedation.
Intervention: Sedation with Midazolam, Fentanyl, and Propofol (Drug)
Users that will stop use 12h before the procedure
Patients that use cannabis and will stop using 12 hours before sedation.
Intervention: Extraction of teeth (Procedure)
Outcomes
Primary Outcomes
Propofol dose in milligrams
Time Frame: During the procedure
Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use
Secondary Outcomes
- Heart rate in beats per minute(During the procedure)
- Blood pressure in millimeters of mercury(During the procedure)
- Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale(During the procedure)