NIPH Clinical Trials Search

JRCT ID: jRCTs061220052

Registered date:30/08/2022

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedAnxiety or fear of dental treatment
Date of first enrollment20/09/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)An intravenous route will be secured for the study subjects and an initial single dose of 0.05 mg/kg of remimazolam will be followed by a continuous dose at 0.35 mg/kg/h. Adjust single or continuous dose rate as appropriate to maintain adequate sedation levels (MOAA/S score 2 to 4). If the patient is determined to be deeply sedated (MOAA/S sedation score 0 or 1), reduce the remimazolam continuous dose by 0.05 mg/kg/h from the set rate. If the depth of sedation is judged to be shallow, increase the continuous dose by 0.05 mg/kg/h from the set rate after a single intravenous dose of 1 mg of remimazolam. The maximum rate of administration should be limited to 0.6 mg/kg/h.


Primary OutcomeThe success rate of remimazolam alone in dental procedures under intravenous sedation. Success is defined as an optimal level of sedation achieved with remimazolam alone during a dental procedure, and the percentage of study subjects meeting the criteria for success in the population analyzed.
Secondary OutcomeSecondary endpoints 1. Time from start of remimazolam administration to optimal sedation level 2. Remimazolam dose 3. Change over time in the depth of sedation (MOAA/S score) of study subjects 4. Changes over time in the patient status index (PSi) by electroencephalogram (EEG) monitoring of the research subjects 5. Remimazolam concentration in blood of study subjects 6. Time from the end of continuous remimazolam administration until the patient is able to return home 7. Memory of the study subject during the dental procedure Safety endpoints 1. Frequency, rate, and severity of adverse events 2. Respiratory system evaluation (1) Change in SpO2 over time (2) Change over time in EtCO2 (3) Change over time in respiratory rate (4) Presence of upper airway obstruction (snoring, seesaw breathing) 3. Cardiovascular system evaluation (1) Change over time in pulse rate (2) Changes in blood pressure (systolic and diastolic) over time (3) Electrocardiographic findings (4) Changes over time in non-invasive continuous estimated cardiac output (esCCO) 4. Assessment of arousal Presence or absence of re-sedation after awakening (from the end of remimazolam administration to leaving the examination room) No staggering or falls (from the time the patient leaves the clinic to the time the patient returns home) 5. Whether antagonist (flumazenil) was administered due to delayed arousal 6. Re-sedation in patients treated with flumazenil 7. Oxygen administration 8. Manual ventilation

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 65age old
Include criteria1. 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
Exclude criteria1. 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

Related Information


Public contact
Name Oue Kana
Address Kasumi 1-2-3 Minami-ku, Hiroshima city, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5733
Affiliation Hiroshima University Hospoital
Scientific contact
Name Oue Kana
Address Kasumi 1-2-3 Minami-ku, Hiroshima city, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5733
Affiliation Hiroshima University Hospoital