Impact of Cannabis Use During Third Molar Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-99
SponsorUniversity of Michigan
About this trial
This study is for people scheduled to have their wisdom teeth (third molars) removed and are going to receive drug through an IV to put them to sleep.
The researchers are studying two groups: one group of people who report using recreational marijuana/THC/cannabis and another group who report not using it. They want to look at how both users and non-users do during the tooth removal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide a signed and dated informed consent form.
Willing to comply with all study procedures and be available for the duration of the study.
Aged ≥ 16 years old.
Presence at least one mandibular 3rd molar
Disqualifiers
Pathology (cyst or tumor) associated with the third molar tooth;
Health comorbidities (BMI 40 and above, and severe cardiovascular disease);
Pregnancy or lactation
Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Trial population
The study population is patients who are scheduled for third molar extraction surgery under IV sedation.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
242 Participants
are grouped into 2 trial groupsGroup A: marijuana/THC/cannabis users
Group B: Non marijuana/THC/cannabis users
Trial outcomes
Primary outcomes
1
Midazolam administered
Amount (mg) of midazolam administered during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The amount of these medications is registered by the timing of each administration, as well as the total amount of each medication given throughout the procedure.
Time frame
The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration2
Mean arterial pressure
Measurements of mean arterial pressure (MAP - mmHG) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.
Time frame
The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.3
Heart rate
Measurements of heart rate (HR - bpm) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.
Time frame
The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.4
Carbon dioxide level
Measurements of carbon dioxide level (CO2 - %) at five time points during third molar removal surgeries utilizing deep (IV) sedation in patients who are cannabis users versus cannabis non-users. The five-time points are: baseline (TB), 5 minutes after initial sedative drug administration (T5), 10 minutes after drug administration (T10), 20 minutes after drug administration (T20), and 30 minutes after drug administration (T30). Measurements on the patient discharge information are included in the data.
Time frame
The time frame spans the third molar removal surgery from baseline at surgery appointment to 30 minutes after initial sedative drug drug administration.Secondary outcomes
1
Complications
Describe and compare intraoperative complications and post-op complications between patients who regularly use cannabis and patients who do not use cannabis.
Time frame
From tooth removal start to end of study2
Cannabis level
Correlate the amount of cannabis detected in the hair/nails/teeth before surgery with perioperative and postoperative outcomes in patients who regularly use cannabis.
Time frame
From enrollment until end of the study3
Depth of Sedation
Compare the depth of sedation (ASA classification) measured every five minutes between patients who regularly use cannabis and those who do not
Time frame
From tooth removal start to end of tooth removalSponsors and contacts
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Source ClinicalTrials.gov