Efficacy and safety of general anesthetics

JRCT ID: jRCTs061230049

Registered date:17/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Scheduled non-cardiac surgeries under general anesthesia
• Date of first enrollment: 08/02/2024
• Target sample size: 69
• Study type: Interventional
• Intervention(s): 69 patients are divided randomly into three groups: bolus group A, bolus group B and continuous group, and 23 patients are involved in each group. In advance, anesthesiologists or nurses secure an intravenous line for each patient in the operation room or the patient room. During induction of general anesthesia, 0.1 mg/kg of remimazolam is injected to patients of bolus group A for about one minute, and 0.2 mg/kg is injected to those of bolus group B. Rescue of 0.05 mg/kg is injected if patients of either bolus group don't get loss of consciousness two minutes after first administration of remimazolam. On the other hand, 12 mg/kg/h of remimazolam is continuously injected for patients of continuous group. For all groups, continuous injection with 1 mg/kg/h of remimazolam is started after patients get loss of consciousness. And dose of remimazolam is fixed to 1 mg/kg/h until the end of intubation. 0.3 ug/kg/min of remifentanil is also administered for all patients during induction of general anesthesia. The time from administration of general anesthetics to loss of consciousness is analysed between bolus group A and continuous group, and between bolus group B and continuous group, while vital signs such as blood pressure, heart rate, saturation of percutaneous oxygen and electroencephalogram are monitored until patients are intubated.

Outcome(s)

• Primary Outcome: The time from administration of general anesthetics to loss of consciousness (seconds)
• Secondary Outcome: The rate of change in blood pressure and heart rate during induction of general anesthesia

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Patients undergoing scheduled non-cardiac surgeries under general anesthesia
2. Patients aged 18 to 80
3. Patients with ASA-PS classification 1 or 2
4. Patients with BMI 18.5 to 30
5. Patients who can understand our explanation well enough, agree and sign the consent forms of their own will

Exclude criteria

1. Patients with heavy use of alcohol (over 60 g per day)
2. Patients who have or previously had an addiction to alcohol or any other drugs
3. Patients with common use of benzodiazepines
4. Patients with acute angle-closed glaucoma, myasthenia gravis or hypersensitivity to remimazolam
5. Patients with severe mental disorders
6. Patients with encephalopathy
7. Patients who are pregnant or lactating
8. Researchers who are directly involved in this study or other clinical studies, or their families
9. Patients who are judged inappropriate for this study

Related Information

• Primary Sponsor: Miyoshi Hirotsugu
• Secondary Sponsor: Kido Kenshiro