Fully Automated Anesthesia, Analgesia and Fluid Management

Phase 1

Completed

• Conditions: Drug Delivery System Malfunction; Underdosing of Other General Anesthetics; General Anesthetic Drug Overdose; Adverse Effect of Intravenous Anesthetics, Sequela; Complication of Anesthesia; Hemodynamic Instability
• Interventions: Other: BIS XP, Covidien, Ireland; Other: EV-1000 TM, Edwards Lifesciences, Irvine, California, USA

• Registration Number: NCT02886806
• Lead Sponsor: Erasme University Hospital

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).

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Study Start: 2016-10
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
high risk vascular surgery	BIS XP, Covidien, Ireland	Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management
high risk vascular surgery	EV-1000 TM, Edwards Lifesciences, Irvine, California, USA	Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management

Primary Outcome Measures

Name	Time	Method
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	at time of surgery

Secondary Outcome Measures

Name	Time	Method
Drug consumption: propofol dose	at time of surgery
number of automatic modifications of the propofol and remifentanil concentrations	at time of surgery
number of patients movements	at time of surgery
Occurrence of burst suppression	at time of surgery
Drug consumption: remifentanil dose	at time of surgery
number of hemodynamic abnormalities requiring treatment	at time of surgery
time to tracheal extubation	at time of surgery
Need for anesthetist interventions over the system during the surgery	at time of surgery
amount of fluid given	at time of surgery
intraoperative awareness	postoperative day 1 or 2
performance of the closed-loop system	at time of surgery
Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes	at time of surgery

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Bruxelles, Belgium