Cannabis Use, Marijuana Usage, Sedation and Analgesia, Wisdom Tooth
Conditions
Keywords
Wisdom tooth, Cannabis use, Sedation and analgesia
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Michigan
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 * American Society of Anesthesiologists (ASA) physical status class I or II
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Midazolam administered | 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. |
| Mean arterial pressure | 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. |
| Heart rate | 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. |
| Carbon dioxide level | 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. |
| Ketamine administered | 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. |
| Fentanyl administered | 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. |
| Propofol administered | 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. |
| Respiratory rate | 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. |
| Oxygen saturation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 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. |
| Cannabis level | 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. |
| Depth of Sedation | 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 |
Countries
United States
Contacts
CONTACTJennifer A Lay-Luskin, MPhil, CCRC
CONTACTBradley Blitstein, DDS
PRINCIPAL_INVESTIGATORPaulo zupelari Gonclaves, DDS, MS, PhD
University of Michigan School of Dentistry/Oral and Maxillofacial Surgery/Hospital Dentistry
Outcome results
None listed