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Development of an automated delivery system of vasoactive drug

Development of an automated delivery system of vasoactive drug for stable blood pressure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220082
Enrollment
20
Registered
2022-05-24
Start date
2022-07-26
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 PS 1-3, scheduled for surgery under total intravenous anesthesia

Interventions

(1) Manually controlled group (Group H): Attending anesthesiologist will start the administration of the circulatory agonists (by injection or by continuous infusion) when the measured blood pressure

Sponsors

Nagata Osamu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Males and females patients over 20 years old at the time of informed consent (2) Patients with ASA Physical Status of 1, 2, and 3 who are scheduled for surgery under general anesthesia with propofol, remifentanil, and rocuronium (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 hypersensitivity to propofol, remifentanil, rocuronium, sugammadex, circulatory agonists (phenylephrine, noradrenaline, etc.), or infusion products (2) Patients who cannot have a bispectral index ("BIS") sensor applied intraoperatively (3) Patients who cannot receive additional doses of rocuronium after the initial single dose (4) Patients who cannot have their blood pressure measured non-invasively during surgery (5) Patients undergoing surgery with hypothermia (6) Patients undergoing cardiovascular surgery (7) Patients who are pregnant or lactating (8) Patients with severely depressed cardiac function (EF less than 40%) or with ventricular tachycardia, or a history of coronary intervention within the last 3 months (9) 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 that mean blood pressure was maintained at 65 mmHg or higher, and systolic blood pressure at 140 mmHg or lower during the evaluation period

Secondary

MeasureTime frame
(1) Percentage of time with abnormally low blood pressure (mean blood pressure 140 mmHg) during the evaluation period (3) Cardiovascular parameters by esCCO (CO, CI,SV, SVI) during the evaluation period (4) Percentage of patients who received noradrenaline during the evaluation period (5) Number (percentage) and average number of additional doses of circulatory agonists administered by the anesthesiologist during the evaluation period (autoregulation group only) (6) Total dose and hourly dose of circulatory agonists and infusions during the evaluation period (7) The percentage of time during which adequate anesthesia was achieved from the start of surgery to the end of surgery (adequate anesthesia range time) (8) Average and standard deviation, quartiles, and interquartile range of mean blood pressure during the evaluation period

Contacts

Public ContactOsamu Nagata

Center Hospital of the National Center for Global Health and Medicine

onagata@hosp.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

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