Cannabis Use on Sedation for Oral Surgery Procedures

University of Oklahoma (OU)

Status and phase: Enrolling; Phase 4

Conditions: Cannabis Use

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05873465

15416

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Non-users

Active Comparator group

Description:

Patients that don't use cannabis and will be submitted to sedation.

Treatment:

Drug: Sedation with Midazolam, Fentanyl, and Propofol

Procedure: Extraction of teeth

Users that will stop use 72h before the procedure

Experimental group

Description:

Patients that use cannabis and will stop using 72 hours before sedation.

Treatment:

Drug: Sedation with Midazolam, Fentanyl, and Propofol

Procedure: Extraction of teeth

Users that will stop use 12h before the procedure

Experimental group

Description:

Patients that use cannabis and will stop using 12 hours before sedation.

Treatment:

Drug: Sedation with Midazolam, Fentanyl, and Propofol

Procedure: Extraction of teeth