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

JRCT ID: jRCTs061220052

Registered date:30/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Anxiety or fear of dental treatment
• Date of first enrollment: 20/09/2022
• Target sample size: 30
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

The 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 Outcome

Secondary 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
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kana Oue
• Source(s) of Monetary Support: Japan Society for the Promotion of Science