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Fully Automated Anesthesia, Analgesia and Fluid Management

NCT02886806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-01-04

No results posted yet for this study

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

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

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

Sponsors & Collaborators

  • Hopital Foch

    collaborator OTHER

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Luc Barvais, MD PhD · Erasme University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02886806 on ClinicalTrials.gov