- This study is a randomized, single-blind, parallel-group trial conducted in Japan. The objective was to compare the maintenance quality of Total Intravenous Anesthesia (TIVA) using an automated anesthesia delivery system versus an anesthesiologist. The aim was to demonstrate the effectiveness of emerging technology in sustaining TIVA at a level comparable to anesthesiologists.
- The study involved patients connected to various monitors, including non-invasive blood pressure (NIBP), electrocardiogram (ECG), oxygen saturation (SpO2), ulnar nerve stimulation electrodes, and a Bispectral Index (BIS) monitor. General anesthesia was induced, and the administration of remifentanil, propofol, and rocuronium was controlled by the automated delivery system based on a predetermined algorithm. The system adjusted doses of remifentanil, propofol, and rocuronium based on pharmacokinetics, BIS monitor, and nerve stimulation, respectively.
- Safety parameters, including postoperative nausea and vomiting (PONV), shivering, delirium, and analgesic usage, showed no significant difference between the manual and automated groups. The incidence of adverse events (AEs) did not significantly differ between the two groups, Importantly, no device failures, serious AEs, AEs causally linked to the study device, or significant safety concerns were observed with the use of the automated anesthesia management system.
- The automated anesthesia delivery system’s clinical application enables the maintenance of sufficient anesthesia through the adjustment of intravenous anesthetic doses, similar to the practices employed by anesthesiologists.
- While the safety data from this automated anesthesia delivery system are promising, it is essential to highlight that the presence of anesthesia professionals remains crucial during procedures as they play a vital role in responding promptly to unforeseen emergencies during surgery.
Summary of "Safety and efficacy of an automated anesthesia delivery system for total intravenous anesthesia with propofol, remifentanil, and rocuronium: a non-inferiority randomized controlled trial versus manually controlled anesthesia"
Summary published May 31, 2023