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

Single center, randomized, double blind, parallel design, prospective clinical trial to compare the safety and efficacy of remimazolam and propofol used in sedation for extraction of third molars

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009638

Enrollment

Registered

2024-07-11

Start date

2023-12-04

Completion date

Unknown

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental group(Remimazolam): After loading 0.7 mg/kg of remimazolam by intravenous injection for 1 minute using an infusion pump, continuous administion at a rate of 0.2 mg/kg/hr during sur

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Difference between the mean value of the lowest intraoperative oxygen saturation between the experimental group and the comparison group	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactSeung-Hwa Ryoo

Seoul National University Dental Hospital

ryooes00@snu.ac.kr+82-2-6256-3290

Outcome results