Investigational research of an automatic control of vasoactive drug and infusion volume

JRCT ID: jRCTs052230120

Registered date:27/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with ASA physical status of 1 and 2, scheduled for surgery under total intravenous anesthes
• Date of first enrollment: 01/12/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Automatically adjust administration of intravenous anesthetics, circulatory agents and infusions based on biological information

Outcome(s)

• Primary Outcome: Percentage of time during the evaluation period when mean blood pressure was 65 mmHg or higher and esSVI was maintained above threshold

Secondary Outcome

1. Percentage of time during the evaluation period when the mean blood pressure was less than 65 mmHg
2. Percentage of time during the evaluation period when esSVI was below threshold
3. Doses of infusion fluids used during the evaluation period
4. Dose of phenylephrine used during the evaluation period
5. Urine volume
6. oliguria
7. Bleeding volume
8. Gastric suction
9. Water balance
10. Ea Value

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Male and female patients over 20 years old at the time of informed consent
2. Patients with ASA physical status of 1 and 2 who are scheduled for surgery under general anesthesia
3. Patients who understand the contents of this study and are willing to provide written informed consent for participation in this study

Exclude criteria

1. Patients with a history of hypersensitive to propofol, remifentanil, rocuronium or sugammadex
2. Patients who cannot connected BIS Sensor for placement on the forehead
3. Patients who cannot received rocuronium after first single dose
4. Patients who cannot measured non-invasive sphygmomanometer
5. Patients undergoing surgery with hypothermia
6. Patients undergoing cardiovascular surgery
7. Patients with supraventricular rhythm irregularities such as atrial fibrillation, atrial flutter, or sinus arrhythmia
8. Patients with expected blood loss of 1000 mL or more
9. Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant
10. Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant

Related Information

• Primary Sponsor: Matsuki Yuka
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development