Fully Automated Anesthesia, Analgesia and Fluid Management
Primary Purpose
General Anesthetic Drug Overdose, Adverse Effect of Intravenous Anesthetics, Sequela, Complication of Anesthesia
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
BIS XP, Covidien, Ireland
EV-1000 TM, Edwards Lifesciences, Irvine, California, USA
Sponsored by
About this trial
This is an interventional treatment trial for General Anesthetic Drug Overdose focused on measuring closed loop, remifentanil, propofol
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,
Sites / Locations
- Erasme University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
high risk vascular surgery
Arm Description
Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Drug consumption: remifentanil dose
Drug consumption: propofol dose
amount of fluid given
number of automatic modifications of the propofol and remifentanil concentrations
number of patients movements
number of hemodynamic abnormalities requiring treatment
time to tracheal extubation
intraoperative awareness
Occurrence of burst suppression
Need for anesthetist interventions over the system during the surgery
performance of the closed-loop system
Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes
Full Information
NCT ID
NCT02886806
First Posted
August 29, 2016
Last Updated
January 3, 2017
Sponsor
Erasme University Hospital
Collaborators
Hopital Foch
1. Study Identification
Unique Protocol Identification Number
NCT02886806
Brief Title
Fully Automated Anesthesia, Analgesia and Fluid Management
Official Title
Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital
Collaborators
Hopital Foch
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high risk vascular surgery
Arm Type
Experimental
Arm Description
Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management
Intervention Type
Other
Intervention Name(s)
BIS XP, Covidien, Ireland
Other Intervention Name(s)
bispectral index
Intervention Description
Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
Intervention Type
Other
Intervention Name(s)
EV-1000 TM, Edwards Lifesciences, Irvine, California, USA
Intervention Description
Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Drug consumption: remifentanil dose
Time Frame
at time of surgery
Title
Drug consumption: propofol dose
Time Frame
at time of surgery
Title
amount of fluid given
Time Frame
at time of surgery
Title
number of automatic modifications of the propofol and remifentanil concentrations
Time Frame
at time of surgery
Title
number of patients movements
Time Frame
at time of surgery
Title
number of hemodynamic abnormalities requiring treatment
Time Frame
at time of surgery
Title
time to tracheal extubation
Time Frame
at time of surgery
Title
intraoperative awareness
Time Frame
postoperative day 1 or 2
Title
Occurrence of burst suppression
Time Frame
at time of surgery
Title
Need for anesthetist interventions over the system during the surgery
Time Frame
at time of surgery
Title
performance of the closed-loop system
Time Frame
at time of surgery
Title
Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes
Time Frame
at time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Barvais, MD PhD
Organizational Affiliation
Erasme University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Erasme University Hospital
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Fully Automated Anesthesia, Analgesia and Fluid Management
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