Development of an automated delivery system of vasoactive drug

Not Applicable

• Conditions: Patients with ASA PS 1-3, scheduled for surgery under total intravenous anesthesia

• Registration Number: JPRN-jRCTs032220082
• Lead Sponsor: agata Osamu

Brief Summary

This study confirmed that a very high percentage of patients develop hypotension during general anesthesia, that the automatic administration control system for circulatory agonists works properly, and that adjustment of the administration of circulatory agonists by the automatic administration control system when abnormal hypotension is observed is no less effective than anesthesiologists' administration of circulatory agonists to recover from abnormal hypotension.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Study Completion: 2022-12-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
(1) Percentage of time with abnormally low blood pressure (mean blood pressure <65 mmHg) during the evaluation period<br>(2) Percentage of time with abnormal hypertension (systolic blood pressure >140 mmHg) during the evaluation period<br>(3) Cardiovascular parameters by esCCO (CO, CI,SV, SVI) during the evaluation period<br>(4) Percentage of patients who received noradrenaline during the evaluation period<br>(5) Number (percentage) and average number of additional doses of circulatory agonists administered by the anesthesiologist during the evaluation period (autoregulation group only)<br>(6) Total dose and hourly dose of circulatory agonists and infusions during the evaluation period<br>(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)<br>(8) Average and standard deviation, quartiles, and interquartile range of mean blood pressure during the evaluation period