Research for automatic control of infusion volume

Phase 2

• Conditions: Patients with ASA physical status of 1 and 2, scheduled for surgery under total intravenous anesthes

• Registration Number: JPRN-jRCTs052220147
• Lead Sponsor: Matsuki Yuka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-05
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of time the mean blood pressure was maintained at 65 mmHg or higher during the evaluation period

Secondary Outcome Measures

Name	Time	Method
1. Percentage of time during the evaluation period when esSVI was below threshold<br>2. Total and hourly doses of infusion fluids used during the evaluation period<br>3. Total dose of phenylephrine used during the evaluation period<br>4. Number of single doses of phenylephrine used during the evaluation period<br>5. Urine and bleeding volume<br>6. Water balance<br>7. Ea Value