Cannabis Use on Sedation for Oral Surgery Procedures

Phase 4

Recruiting

• Conditions: Cannabis Use
• Interventions: Drug: Sedation with Midazolam, Fentanyl, and Propofol; Procedure: Extraction of teeth

• Registration Number: NCT05873465
• Lead Sponsor: University of Oklahoma

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 available

Study Timeline

• Study First Submitted: 2023-03-13
• Study Start: 2023-03-14
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-05
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-users	Sedation with Midazolam, Fentanyl, and Propofol	Patients that don't use cannabis and will be submitted to sedation.
Non-users	Extraction of teeth	Patients that don't use cannabis and will be submitted to sedation.
Users that will stop use 72h before the procedure	Sedation with Midazolam, Fentanyl, and Propofol	Patients that use cannabis and will stop using 72 hours before sedation.
Users that will stop use 72h before the procedure	Extraction of teeth	Patients that use cannabis and will stop using 72 hours before sedation.
Users that will stop use 12h before the procedure	Sedation with Midazolam, Fentanyl, and Propofol	Patients that use cannabis and will stop using 12 hours before sedation.
Users that will stop use 12h before the procedure	Extraction of teeth	Patients that use cannabis and will stop using 12 hours before sedation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Heart rate in beats per minute	During the procedure	Compare how the heart rate behave during the procedure in each group
Blood pressure in millimeters of mercury	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	During the procedure	Compare the difference in sedation quality during the procedure in each group

Trial Locations

Locations (1)

College of Dentistry; 🇺🇸 Oklahoma City, Oklahoma, United States