NCT02886806

Fully Automated Anesthesia, Analgesia and Fluid Management

Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• General Anesthetic Drug Overdose
• Adverse Effect of Intravenous Anesthetics, Sequela
• Complication of Anesthesia
• Drug Delivery System Malfunction
• Hemodynamic Instability
• Underdosing of Other General Anesthetics

Interventions

Type	Name	Description
OTHER	BIS XP, Covidien, Ireland	Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
OTHER	EV-1000 TM, Edwards Lifesciences, Irvine, California, USA	Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-09-01
• Last updated: 2017-01-04

Locations

1 site across 1 country: Belgium