Development of an automated delivery system of vasoactive drug

JRCT ID: jRCTs032220082

Registered date:24/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with ASA PS 1-3, scheduled for surgery under total intravenous anesthesia
• Date of first enrollment: 26/07/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

(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 falls below the abnormal hypotension threshold, and manage the administration of the drug in order to maintain the blood pressure within the target range.
(2) Automated adjustment group (Group R): The automatic administration control system of circulatory agonists will be activated at the same time as the automatic delivery of intravenous anesthetics is started, and when the measured blood pressure falls below the abnormal hypotension threshold, the system will start the automated delivery of circulatory agonists in order to maintain the blood pressure within the target range.

Outcome(s)

• Primary Outcome: 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 Outcome

(1) Percentage of time with abnormally low blood pressure (mean blood pressure <65 mmHg) during the evaluation period
(2) Percentage of time with abnormal hypertension (systolic 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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nagata Osamu
• Source(s) of Monetary Support: NIHON KOHDEN CORPORATION,National Center for Global Health and Medicine, National Research an d Development Agency