CompletedPhase 1

Fully Automated Anesthesia, Analgesia and Fluid Management

Belgium13 participantsStarted 2016-10

Plain-language 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

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

What they're measuring

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

Timeframe: at time of surgery

Trial details

NCT IDNCT02886806

SponsorErasme University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

View on ClinicalTrials.gov More General Anesthetic Drug Overdose trials