A study to determine the efficacy and safety of using remimazolam for dental procedures under sedation.

Phase 2

• Conditions: Anxiety or fear of dental treatment

• Registration Number: JPRN-jRCTs061220052
• Lead Sponsor: Kana Oue

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Those who undergoing dental treatment by Oral and Maxillofacial Reconstructive Surgery under intravenous sedation in Stress-free dental outpatient setting
2. Age: between 18 and 65 years old. Sex: male and female
3. ASA-PS: 1 or 2
4. BMI: 18.5 kg/m2 or more, less than 30 kg/m2
5. Those who voluntarily provided written informed consent upon receiving sufficient explanation and understanding the content of the study

Exclusion Criteria

1. Heavy drinkers (equivalent to 60 g/day of pure alcohol)
2. Those with complications of drug abuse and dependence and alcohol dependence or a history of them
3. Those who regularly used benzodiazepines
4. Those with diseases in which benzodiazepines are contraindicated, such as those with acute angle closure glaucoma and myasthenia gravis, or a history of hypersensitivity to benzo diazepines
5. Those with severe psychiatric disorder
6. Those with structural brain disorder
7. Those without the ability to provide informed consent due to complications of dementia, etc.
8. Those treated for severe or poorly controlled (ASA PS class 3 or greater) respiratory diseases (bronchial asthma, etc.), cardiovascular disease (hypertension, etc.), neurological disorders (convulsions, etc.), digestive diseases, liver diseases, kidney disease, hematopoietic diseases, mental illness, endocrine diseases, etc. or with a history of them who were deemed ineligible for the study for security reasons by the principal investigator or sub-investigator
9. Those who are pregnant or lactating women, and who may be pregnant or wish to have a baby
10. Principal investigators, employees of the institution, or their family members who are directly involved in this or other clinical research
11. Others who were determined to be ineligible for the study by the principal investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified