Fully Automated Anesthesia, Analgesia and Fluid Management

NCT ID: NCT02886806

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-01-31

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high risk vascular surgery

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

Group Type: EXPERIMENTAL

BIS XP, Covidien, Ireland

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

Interventions

BIS XP, Covidien, Ireland

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Other Intervention Names

bispectral index

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luc Barvais

Professor and head of the cardiothoracic and vascular anesthesia Clinics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luc Barvais, MD PhD

Role: STUDY_DIRECTOR

Erasme University Hospital

Locations

Erasme University Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

P2016/328

Identifier Type: -

Identifier Source: org_study_id