Cannabis Use on Sedation for Oral Surgery Procedures

Cannabis Use Clinical Trial

Official title:

Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873465
• Other study ID #: 15416
• Status: Recruiting
• Phase: Phase 4
• Start date: March 14, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Drug:
• Sedation with Midazolam, Fentanyl, and Propofol
Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol

Procedure:
• Extraction of teeth
The necessary teeth will be extracted

Locations

Country	Name	City	State
United States	College of Dentistry	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate in beats per minute	Compare how the heart rate behave during the procedure in each group	During the procedure
Secondary	Blood pressure in millimeters of mercury	Compare how the blood pressure behave during the procedure in each group	During the procedure
Secondary	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