Impact of Cannabis Use During Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Midazolam administered
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
marijuana/THC/cannabis users
marijuana/THC/cannabis users
Non marijuana/THC/cannabis users
Non marijuana/THC/cannabis users
结局指标
主要结局
Midazolam administered
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Complications(From tooth removal start to end of study)
- Cannabis level(From enrollment until end of the study)
- Depth of Sedation(From tooth removal start to end of tooth removal)
研究者
Paulo Zupelari Goncalves
Paulo Zupelari Goncalves Title Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery/Hospital Dentistry, School of Dentistry
University of Michigan