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Clinical trial of hemodynamic autoregulation software for patients undergoing inhalation anesthesia

A randomized controlled trial of hemodynamic autoregulation software versus manual control in patients undergoing inhalation anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2052240169
Enrollment
60
Registered
2024-10-28
Start date
2024-11-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with ASA physical status of 1 and 2, scheduled for surgery under inhalation anesthesia General anesthesia

Interventions

Sponsors

Shigemi Kenji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitive to sevoflurane, 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.

Design outcomes

Primary

MeasureTime frame
Percentage of time during the evaluation period during which mean blood pressure was maintained at 65mmHg or more and less than 110mmHg

Secondary

MeasureTime frame
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

Contacts

Public ContactKyohei Watanabe

University of Fukui Hospital

kyohei@u-fukui.ac.jp+81-776-61-8529

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026