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Completed

NCT Number: NCT02886806

Fully Automated Anesthesia, Analgesia and Fluid Management

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

About this 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.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

BIS XP, Covidien, Ireland

Other

Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland

Other names: bispectral index

EV-1000 TM, Edwards Lifesciences, Irvine, California, USA

Other

Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA

Primary outcomes

  1. 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 outcomes

  1. Drug consumption: remifentanil dose

    Time frame: at time of surgery

  2. Drug consumption: propofol dose

    Time frame: at time of surgery

  3. amount of fluid given

    Time frame: at time of surgery

  4. number of automatic modifications of the propofol and remifentanil concentrations

    Time frame: at time of surgery

  5. number of patients movements

    Time frame: at time of surgery

  6. number of hemodynamic abnormalities requiring treatment

    Time frame: at time of surgery

  7. time to tracheal extubation

    Time frame: at time of surgery

  8. intraoperative awareness

    Time frame: postoperative day 1 or 2

  9. Occurrence of burst suppression

    Time frame: at time of surgery

  10. Need for anesthetist interventions over the system during the surgery

    Time frame: at time of surgery

  11. performance of the closed-loop system

    Time frame: at time of surgery

  12. Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes

    Time frame: at time of surgery

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • Hopital Foch

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2016
Registry last updated
Jan 4, 2017

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.

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