Clinical trial NCT02886806: Fully Automated Anesthesia, Analgesia and Fluid Management
Official title: Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Keywords: closed loop
remifentanil
propofol
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Hopital Foch
First posted: 2016-09-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* patients scheduled for high risk vascular surgery
* Patients American Society Anesthesiologist classification: 3 or 4

Exclusion Criteria:

* age less than 18 years,
* patients with arrhythmias like atrial fibrillation
* allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
* pregnant woman
* combined general and regional anesthesia,

Primary outcomes:
measure: 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
timeFrame: at time of surgery
Secondary outcomes:
measure: Drug consumption: remifentanil dose
timeFrame: at time of surgery
measure: Drug consumption: propofol dose
timeFrame: at time of surgery
measure: amount of fluid given
timeFrame: at time of surgery
measure: number of automatic modifications of the propofol and remifentanil concentrations
timeFrame: at time of surgery
measure: number of patients movements
timeFrame: at time of surgery
measure: number of hemodynamic abnormalities requiring treatment
timeFrame: at time of surgery
measure: time to tracheal extubation
timeFrame: at time of surgery
measure: intraoperative awareness
timeFrame: postoperative day 1 or 2
measure: Occurrence of burst suppression
timeFrame: at time of surgery
measure: Need for anesthetist interventions over the system during the surgery
timeFrame: at time of surgery
measure: performance of the closed-loop system
timeFrame: at time of surgery
measure: Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme University Hospital
name: Luc Barvais, MD PhD
role: STUDY_DIRECTOR
References: