Effect of remimazolam on autonomic circulatory control function

JRCT ID: jRCT1031240189

Registered date:27/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases that require general anesthesia in the operating room
• Date of first enrollment: 27/06/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Assign anesthesia maintenance to propofol group and remimazolam group.
In the propofol group, propofol 2-2.5 mg/kg was administered intravenously, and in the remimazolam group, remimazolam 12 mg/kg/hour was administered intravenously to induce sleep.
Anesthesia maintenance should be 4-10 mg/kg/h in the propofol group and 1-2 mg/kg/h in the remimazolam group.

Outcome(s)

• Primary Outcome: Spontaneous fluctuation waveforms of heart rate and blood pressure obtained from electrocardiogram and arterial pressure waveforms
• Secondary Outcome: Heart rate, blood pressure, cardiac output, respiratory rate, end-tidal carbon dioxide concentration, percutaneous arterial oxygen saturation, BIS value

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1) Persons who are between 18 and 65 years old at the time of obtaining consent (pre-operative examination)
2) Cases with American Society of Anesthesiologists pre-anesthesia risk assessment 2 or lower (ASA classification 1: No organic, physiological, biochemical or mental abnormality. 2: Mild to moderate systematic disorder. 3: Severe systematic disorder. 4: Severe systematic disease that is threatening life and cannot be cured even with surgery.)
3) Subjects who have received sufficient explanation at the pre-operative examination to participate in this study, and who have given their voluntary written informed consent with full understanding.

Exclude criteria

1)Patients with autonomic nerve imbalance
2)Patients with hypertension
3) Cases with moderate to severe systemic complications (American Society of Anesthesiologists preanesthesia risk assessment 3 or higher)
4)Poorly controlled diabetic patients
5) Patients taking oral medications that affect the autonomic nervous system
6)Other persons who are judged by the research director to be inappropriate as research subjects.
7) Persons who have requested refusal to participate in this research

Related Information

• Primary Sponsor: Sato Hanae