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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA
Erasme University Hospital
Brussels, Belgium
The percentage of adequate anesthesia defined as a BIS between between 40 and 60, a SVV < 13% and/or cardiac index > 2.5 litre/min/m² for more/equal of 85% of the surgical time
Time frame: at time of surgery
Drug consumption: remifentanil dose
Time frame: at time of surgery
Drug consumption: propofol dose
Time frame: at time of surgery
amount of fluid given
Time frame: at time of surgery
number of automatic modifications of the propofol and remifentanil concentrations
Time frame: at time of surgery
number of patients movements
Time frame: at time of surgery
number of hemodynamic abnormalities requiring treatment
Time frame: at time of surgery
time to tracheal extubation
Time frame: at time of surgery
intraoperative awareness
Time frame: postoperative day 1 or 2
Occurrence of burst suppression
Time frame: at time of surgery
Need for anesthetist interventions over the system during the surgery
Time frame: at time of surgery
performance of the closed-loop system
Time frame: at time of surgery
Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes
Time frame: at time of surgery
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