Clinical trial to compare the safety and efficacy of remimazolam and propofol used during sedation for third molar extraction surgery. to compare the safety and efficacy of remimazolam and propofol used in the sedation for extraction of third molars

Not Applicable

Recruiting

Conditions: Diseases of the digestive system

Registration Number: KCT0009638

Lead Sponsor: Seoul National University Dental Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 34

Inclusion Criteria

1. Patients who are aged between 19 and 60 years old
2. Patients who are American Society of Anesthesiologists physical status I or II
3. Patients who are scheduled to have extraction of third molars under sedation
4. Patients with a body mass index (BMI) of 18.5 to 30 kg/m2

Exclusion Criteria

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