Clinical trial to compare the safety and efficacy of sedatives used during extraction of third molars
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009637
- Lead Sponsor
- Seoul National University Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 60
1. Patients who are aged between 18 and 40 years old
2. Patients who are American Society of Anesthesiologists physical status I or II
3. Patients who are scheduled to have extraction of all 4 third molars under sedation
4. Patients with a body mass index (BMI) of 18.5 to 30 kg/m2
1. Patients with hypersensitivity or allergy to sedatives or local anesthetics
2. Patients taking medications that may affect clinical trial results, such as pain relievers, sedatives, and psychiatric medications
3. Patients with Mallampati Class III or IV
4. Patients who are pregnant or breastfeeding
5. Patients with liver, kidney or brain dysfunction
6. Patients with sleep apnea
7. Patients with myasthenia gravis
8. Patient unable to read or understand consent form
9. Other patients determined by the investigator to be excluded
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between the mean value of the lowest intraoperative oxygen saturation between the experimental group and the comparison group
- Secondary Outcome Measures
Name Time Method Demographic information, dental anxiety scale, sleep time ratio, Pederson difficulty index, level of sedation;observer assessment of alertness/sedation scale, bispectral index, vital signs(blood pressure, puls, oxygen saturation), ETCO2, pain level(NRS), local anesthetic dose, dosage and frequency of sedative drugs, drug adverse reaction;observer assessment of alertness/sedation scale, vital signs(blood pressure, puls, oxygen saturation), ETCO2, pain level(NRS), satisfaction(NRS), memory, drug adverse reaction