Comparison of satisfaction in dental treatments using patient-controlled sedation methods with midazolam, remimazolam, and dexmedetomidine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008615

Enrollment

Registered

2023-07-17

Start date

2023-07-24

Completion date

Unknown

Last updated

2023-08-01

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

Conditions

None listed

Interventions

Drug : Using the Microsoft Excel program, a random allocation table was generated to assign research subjects to the respective groups (Experimental Group 1 - Remimazolam, Experimental Group 2 - Dexme

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients aged 20 years or older and under 60 years old. ? Patients who meet the American Society of Anesthesiologists Physical Status (ASA PS) criteria of I or II. ? Patients with a body mass index (BMI) ranging from 18.5 to 30. ? Patients who have planned dental treatment under local anesthesia in oral and maxillofacial surgery and have given consent. ? Cases where dental treatment is expected to take place within 2 hours. ? Patients who have been informed about and consented to participate in a clinical trial on Patient-controlled sedation in dental anesthesia.

Exclusion criteria

Exclusion criteria: ? Patients with hypersensitivity or allergies to sedatives or local anesthetics. ? Patients who are currently taking medications, such as analgesics, sedatives, psychiatric drugs, or any other medication that could potentially influence the results of the clinical trial. ? Patients classified as Mallampati III or IV. ? Patients who are pregnant or breastfeeding. ? Patients with liver, kidney, or brain function disorders. ? Patients with sleep apnea. ? Patients with Myasthenia gravis. ? Patients who are unable to read or understand the informed consent form. ? Other patients for whom the exclusion by the investigator is deemed necessary.

Design outcomes

Primary

Measure	Time frame
Level of sedation (OAA/S - Observer's Assessment of Alertness/Sedation), Vital signs (blood pressure, heart rate, oxygen saturation), Pain level (NRS - Numeric Rating Scale);Bispectral Index (BIS), Number of times the button on the patient-controlled sedation device was pressed/Total amount of medication administered, Additional sedative dosage/administration frequency, Dosage of local anesthetic used;Anesthesiologist's/dentist's/patient's subjective satisfaction with patient-controlled sedation, Intraoperative memory assessment	—

Measure

Time frame

Level of sedation (OAA/S - Observer's Assessment of Alertness/Sedation), Vital signs (blood pressure, heart rate, oxygen saturation), Pain level (NRS - Numeric Rating Scale);Bispectral Index (BIS), Number of times the button on the patient-controlled sedation device was pressed/Total amount of medication administered, Additional sedative dosage/administration frequency, Dosage of local anesthetic used;Anesthesiologist's/dentist's/patient's subjective satisfaction with patient-controlled sedation, Intraoperative memory assessment

—

Secondary

Measure	Time frame
Demographic information, Height, Weight, Mallampati classification, Medical history, Dental anxiety scale, Sleep duration;Occurrence of adverse reactions	—

Countries

Korea, Republic of

Contacts

Public ContactKwang-Suk Seo

Seoul National University Dental Hospital

stone90n@gmail.com+82-2-6256-3300

Outcome results