Clinical trial of hemodynamic autoregulation software for patients undergoing total intravenous anesthesia

JRCT ID: jRCT2052240168

Registered date:28/10/2024

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: 05/11/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Automatic controlled group(experimental group): Circulatory agonists and intravenous fluids are automatically delivered by the automated system.
Manual group (control group): Circulatory agonists and intravenous fluids are manually adjusted by the attending anesthesiologist, as usual, considering the patient's condition and surgical situation.

Outcome(s)

• Primary Outcome: Percentage of time during the evaluation period during which mean blood pressure was maintained at 65mmHg or more and less than 110mmHg

Secondary Outcome

1. Percentage of time during the evaluation period when esSVI was above the threshold
2. Heart rate during the evaluation period
3. Doses of infusion fluids used during the evaluation period
4. Dose of phenylephrine used during the evaluation period
5. Urine volume
6. Bleeding volume
7. Water balance
8. Percentage of time during surgery when sedation, analgesia, and muscle relaxation were adequately maintained
9. Percentage of time during surgery when both sedation and analgesia were adequately maintained

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 1and 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 and TOF Sensor for placement on the forehead
3. Patients who cannot measured non-invasive sphygmomanometer
4. Patients undergoing surgery with hypothermia
5. Patients undergoing cardiovascular surgery
6. Patients with supraventricular rhythm irregularities such as atrial fibrillation, atrial flutter, or sinus arrhythmia
7. Patients with expected blood loss of 1000 mL or more
8. Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant
9. Patients who participated in another trial
10. Patients who are determined not to be eligible for participation in this study by the research director.

Related Information

• Primary Sponsor: Shigemi Kenji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,NIHON KOHDEN CORPORATION