Fully Automated Anesthesia, Analgesia and Fluid Management

NCT02886806 | Completed Phase 1 DMC

• 1 other identifier: P2016/328
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

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

Keywords

closed loop; remifentanil; propofol

Outcome Measures

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

  at time of surgery

Secondary Outcomes (12)

• Drug consumption: remifentanil dose

  at time of surgery

• Drug consumption: propofol dose

  at time of surgery

• amount of fluid given

  at time of surgery

• number of automatic modifications of the propofol and remifentanil concentrations

  at time of surgery

• number of patients movements

  at time of surgery

Study Arms (1)

high risk vascular surgery

EXPERIMENTAL

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

Other: BIS XP, Covidien, Ireland; Other: EV-1000 TM, Edwards Lifesciences, Irvine, California, USA

Interventions

BIS XP, Covidien, Ireland OTHER

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

Also known as: bispectral index

high risk vascular surgery

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

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

high risk vascular surgery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for high risk vascular surgery
• Patients American Society Anesthesiologist classification: 3 or 4

You may not qualify if:

• 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,

Sponsors & Collaborators

• Erasme University Hospital: lead
• Hopital Foch: collaborator

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Luc Barvais, MD PhD

  Erasme University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and head of the cardiothoracic and vascular anesthesia Clinics

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

BE (1)