University of Michigan School of Dentistry/ Oral and Maxillofacial Surgery
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
NCT Number: NCT07423195
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.
Interested in participating?
Request Info16 year–99 year
All sexes
Observational
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
When the researchers look at how both users and non-users do during the tooth removal, they will look at things like: how much medicine you need to be put to sleep, your body's vital signs like your number of heart beats, your blood pressure, and how many time you breathe during a minute.
Researchers will ask you questions about your health. If you report using marijuana/THC/cannabis, a small hair sample (about 1 or 2 inches) or fingernail (about the thickness of two credit cards from all 10 fingers) will be taken before tooth removal to check the amount of marijuana/THC/cannabis in your body. These will be sent to a lab using a number and not your name to protect your privacy and your confidential information. Also, we may be able to use the teeth that we take out to check the levels. These teeth are usually thrown away after your tooth removal.
If you report not using marijuana/THC/cannabis, a urine sample will be collected before tooth removal for a quick test to check for marijuana/THC/cannabis. We will also have you fill out a questionnaire about your pain levels and cannabis/THC use if you use it.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: The time frame spans the third molar removal surgery from baseline at surgery appointment to thirty minutes after initial sedative drug administration
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 30 minutes after initial sedative drug drug administration.
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.
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.
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 thirty minutes after initial sedative drug administration
Amount (mg) of ketamine 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 administration
Amount (mg) of Fentanyl 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 administration
Description: Amount (mg) of propofol 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 30 minutes after initial sedative drug drug administration.
Measurements of respiratory rate (RR - breaths per minute) 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.
Measurements of oxygen saturation level (O2 - %) 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: From tooth removal start to end of study
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 enrollment until end of the study
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 tooth removal start to end of tooth removal
Compare the depth of sedation (ASA classification) measured every five minutes between patients who regularly use cannabis and those who do not
Contact information is provided by the study sponsor or research team.
Bradley Blitstein, DDS
CONTACT
Jennifer A Lay-Luskin, MPhil, CCRC
CONTACT
Oral and Maxillofacial Surgery
University of Michigan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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