Cannabis Use on Sedation for Oral Surgery Procedures

• ClinicalTrials.gov Identifier: NCT05873465
• Recruitment Status: Recruiting
• First Posted: May 24, 2023
• Last Update Posted: February 14, 2024
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: March 13, 2023
• First Posted Date: May 24, 2023
• Last Update Posted Date: February 14, 2024
• Actual Study Start Date: March 14, 2023
• Estimated Primary Completion Date: May 21, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 15, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cannabis Use on Sedation for Oral Surgery Procedures
• Official Title: Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Cannabis Use

Intervention

• Drug: Sedation with Midazolam, Fentanyl, and Propofol
  Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol
  Other Name: Sedation
• Procedure: Extraction of teeth
  The necessary teeth will be extracted
  Other Name: Surgical procedure

Study Arms

• Active Comparator: Non-users
  Patients that don't use cannabis and will be submitted to sedation.
  Interventions:

  • Drug: Sedation with Midazolam, Fentanyl, and Propofol
  • Procedure: Extraction of teeth
• Experimental: Users that will stop use 72h before the procedure
  Patients that use cannabis and will stop using 72 hours before sedation.
  Interventions:

  • Drug: Sedation with Midazolam, Fentanyl, and Propofol
  • Procedure: Extraction of teeth
• Experimental: Users that will stop use 12h before the procedure
  Patients that use cannabis and will stop using 12 hours before sedation.
  Interventions:

  • Drug: Sedation with Midazolam, Fentanyl, and Propofol
  • Procedure: Extraction of teeth

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 15, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: May 21, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05873465
• Other Study ID Numbers: 15416
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oklahoma
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Oklahoma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Oklahoma
• Verification Date: February 2024