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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Propofol dose in milligrams
Secondary outcome measures
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
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
455 Previous Clinical Trials
95,863 Total Patients Enrolled
1 Trials studying Cannabis Use
50 Patients Enrolled for Cannabis Use
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need teeth removed.I am older than 18 years.I have undergone medical procedures of similar complexity.My surgery lasted less than 10 minutes or more than 30 minutes.I am currently taking medication for depression or anxiety.My health is severely limited by my disease.I am in good or mild systemic disease according to ASA standards.
Research Study Groups:
This trial has the following groups:- Group 1: Non-users
- Group 2: Users that will stop use 72h before the procedure
- Group 3: Users that will stop use 12h before the procedure
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do patients need to discontinue usage of Users 72 hours before the procedure in order for it to be safe?
"Our team's assessment of the safety profile for users that will discontinue use 72 hours prior to their procedure is a 3, as this treatment has already been approved."
Answered by AI
Are there any opportunities for enrollment in this trial currently?
"According to clinicaltrials.gov, this study is no longer accepting participants; the trial was first made available on May 22nd 2023 and its latest update occurred on 15th May 2023. There are still 127 other trials actively recruiting patients at present though."
Answered by AI
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