Hemodynamic Instability Clinical Trial
Official title:
Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management
based on a combination of several physiological variables (bispectral index [BIS], stroke
volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop
systems (PCLS) in patients undergoing high risk vascular surgery.
All patients will receive total intravenous anesthesia in target controlled infusion mode
using the population pharmacokinetic sets of Schnider for propofol and Minto for
remifentanil to target the effect-site concentration. Infusion Toolbox 95 version 4.11
software (Free University of Brussels, Brussels, Belgium) implemented in a personal computer
serving as a platform for: calculating effect-site concentrations of propofol and
remifentanil; displaying effect-site concentration estimates in real time; providing a user
interface that permits entry of patients' demographic data (sex, age, weight, and height)
and modifications to target concentrations; controlling the propofol and remifentanil
infusion pumps (Alaris Medical, Hampshire, United Kingdom); and recording calculated
effect-site drug concentrations.
All patients will receive a baseline crystalloid infusion (PlasmaLyte, Baxter, Belgium)
delivered by a pump at a rate of 3 mL/ kg/h (Fresenius Kabi, Belgium). Additional fluid was
given using a goal-directed fluid therapy protocol guided by the cardiac output monitor
(EV-1000; Edwards Lifesciences) and consisted of 100 mL boluses (Voluven, Fresenius Kabi,
Germany) delivered by our PCLS (Learning Intravenous Resuscitator [LIR]). For fluid output,
a Q-Core Sapphire Multi-Therapy Infusion Pump (Q-Core, Israel) was controlled by the LIR
using software provided by Q-Core via a serial connection (Commands Server R.01). If
hypotension occurred (defined as mean arterial pressure <20% of baseline blood pressure) and
no fluid is delivered by the LIR, it will be treated by the anesthesiologist using a
vasopressor drug.
In this pilot study, each closed loop also will operate independently, guided only by its
own respective inputs (BIS for the propofol; SV and SVV for the fluid boluses).
The investigators will also measure analgesia using the PhysioDoloris monitoring device
(MDoloris Medical Systems, Lille, France).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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