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General Anesthetic

Cannabis Use on Sedation for Dental Procedures

Phase 4
Recruiting
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the procedure
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study how chronic cannabis use affects dental procedures done with general anesthesia in the clinic.

Who is the study for?
This trial is for adults over 18 who need teeth extracted and are generally healthy (ASA Class I or II). It's specifically looking at how chronic cannabis use affects sedation during these procedures. People with more complex dental issues or other health problems that could complicate sedation aren't eligible.
What is being tested?
The study is testing the effects of regular cannabis use on how well common sedatives (Midazolam, Fentanyl, Propofol) work during tooth extractions. Patients will receive these medications in a controlled clinical setting at the College of Dentistry's Oral and Maxillofacial Surgery Clinic.
What are the potential side effects?
Potential side effects from the sedatives may include drowsiness, dizziness, nausea, memory issues, or slowed breathing. The impact of cannabis on these side effects will be closely monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Propofol dose in milligrams
Secondary study objectives
Blood pressure in millimeters of mercury
Heart rate in beats per minute
Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Users that will stop use 72h before the procedureExperimental Treatment2 Interventions
Patients that use cannabis and will stop using 72 hours before sedation.
Group II: Users that will stop use 12h before the procedureExperimental Treatment2 Interventions
Patients that use cannabis and will stop using 12 hours before sedation.
Group III: Non-usersActive Control2 Interventions
Patients that don't use cannabis and will be submitted to sedation.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,634 Total Patients Enrolled
1 Trials studying Cannabis Use
50 Patients Enrolled for Cannabis Use

Media Library

Propofol (General Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05873465 — Phase 4
Cannabis Use Research Study Groups: Non-users, Users that will stop use 72h before the procedure, Users that will stop use 12h before the procedure
Cannabis Use Clinical Trial 2023: Propofol Highlights & Side Effects. Trial Name: NCT05873465 — Phase 4
Propofol (General Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05873465 — Phase 4
~10 spots leftby May 2025
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