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

agata Osamu0 sites20 target enrollmentMay 24, 2022

ConditionsPatients with ASA PS 1-3, scheduled for surgery under total intravenous anesthesia

Overview

Phase: 未知
Intervention: Not specified
Conditions: Patients with ASA PS 1-3, scheduled for surgery under total intravenous anesthesia
Sponsor: agata Osamu
Enrollment: 20
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

May 24, 2022

End Date

December 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

agata Osamu

Eligibility 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

•(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