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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Erasme University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high risk vascular surgery; Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management	Other: BIS XP, Covidien, Ireland; Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland; Other Names: bispectral index; Other: EV-1000 TM, Edwards Lifesciences, Irvine, California, USA; Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Drug consumption: remifentanil dose	at time of surgery
Drug consumption: propofol dose	at time of surgery
amount of fluid given	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
number of hemodynamic abnormalities requiring treatment	at time of surgery
time to tracheal extubation	at time of surgery
intraoperative awareness	postoperative day 1 or 2
Occurrence of burst suppression	at time of surgery
Need for anesthetist interventions over the system during the surgery	at time of surgery
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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: Hopital Foch
• Investigators: Study Director: Luc Barvais, MD PhD, Erasme University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: propofol; remifentanil; closed loop
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: P2016/328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided