JPRN-jRCTs061220052
Completed
Phase 2
An Exploratory Clinical Study of the Efficacy and Safety of Remimazolam in Dental Procedures Under Intravenous Sedation
Kana Oue0 sites30 target enrollmentAugust 30, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kana Oue
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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