Erasme University Hospital
Brussels, 1070, Belgium
NCT Number: NCT02886806
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
Looking for future studies?
Notify Me18 year–99 year
All sexes
Interventional
Phase 1
Brussels, 1070, Belgium
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
Other names: bispectral index
Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: postoperative day 1 or 2
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Time frame: at time of surgery
Erasme University Hospital
Other
Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03230929
General Anesthetic Drug Overdose
Yangsan, South Korea
View Trial DetailsNCT06043505
Hemodynamic Instability, Infections
Nîmes, France
View Trial DetailsNCT05705115
Fluid Loss, Hemodynamic Instability
Oslo, Norway
View Trial DetailsNCT06270485
Cardiovascular Abnormalities, Cardiovascular Diseases
Berlin, State of Berlin, Germany
View Trial Details