Cannabis Use on Sedation for Oral Surgery Procedures

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.

Official Title
-----------------
Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures

Conditions
-----------------
Cannabis Use

Intervention / Treatment
-----------------
* Drug: Sedation with Midazolam, Fentanyl, and Propofol
* Procedure: Extraction of teeth


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-users<br>Patients that don't use cannabis and will be submitted to sedation. | Drug: Sedation with Midazolam, Fentanyl, and Propofol<br>* Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol<br>* Other names: Sedation;Procedure: Extraction of teeth<br>* The necessary teeth will be extracted<br>* Other names: Surgical procedure;|
| Experimental: Users that will stop use 72h before the procedure<br>Patients that use cannabis and will stop using 72 hours before sedation. | Drug: Sedation with Midazolam, Fentanyl, and Propofol<br>* Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol<br>* Other names: Sedation;Procedure: Extraction of teeth<br>* The necessary teeth will be extracted<br>* Other names: Surgical procedure;|
| Experimental: Users that will stop use 12h before the procedure<br>Patients that use cannabis and will stop using 12 hours before sedation. | Drug: Sedation with Midazolam, Fentanyl, and Propofol<br>* Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol<br>* Other names: Sedation;Procedure: Extraction of teeth<br>* The necessary teeth will be extracted<br>* Other names: Surgical procedure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate in beats per minute | Compare how the heart rate behave during the procedure in each group | During the procedure | 
| Blood pressure in millimeters of mercury | Compare how the blood pressure behave during the procedure in each group | During the procedure | 
| 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 |