Fully Automated Anesthesia, Analgesia and Fluid Management

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

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).

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: high risk vascular surgery
    • Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: at time of surgery

Secondary Measures

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

Participating in This Clinical Trial

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,

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Collaborator
    • Hopital Foch
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luc Barvais, Professor and head of the cardiothoracic and vascular anesthesia Clinics – Erasme University Hospital
  • Overall Official(s)
    • Luc Barvais, MD PhD, Study Director, Erasme University Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.