Fully Automated Anesthesia, Analgesia and Fluid Management

Hemodynamic Instability Clinical Trial

Official title:

Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886806
• Other study ID #: P2016/328
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2016
• Last updated: January 3, 2017
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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,

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effect of Intravenous Anesthetics, Sequela
• Complication of Anesthesia
• Drug Delivery System Malfunction
• Drug Overdose
• General Anesthetic Drug Overdose
• Hemodynamic Instability
• Underdosing of Other General Anesthetics

Intervention

Other:
• BIS XP, Covidien, Ireland
Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
• EV-1000 TM, Edwards Lifesciences, Irvine, California, USA
Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	Hopital Foch

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Drug consumption: remifentanil dose		at time of surgery	No
Secondary	Drug consumption: propofol dose		at time of surgery	No
Secondary	amount of fluid given		at time of surgery	No
Secondary	number of automatic modifications of the propofol and remifentanil concentrations		at time of surgery	No
Secondary	number of patients movements		at time of surgery	No
Secondary	number of hemodynamic abnormalities requiring treatment		at time of surgery	No
Secondary	time to tracheal extubation		at time of surgery	No
Secondary	intraoperative awareness		postoperative day 1 or 2	No
Secondary	Occurrence of burst suppression		at time of surgery	No
Secondary	Need for anesthetist interventions over the system during the surgery		at time of surgery	No
Secondary	performance of the closed-loop system		at time of surgery	No
Secondary	Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes		at time of surgery	No