Design of a Closed-loop Controller Based on the Bispectral Index (BIS) Effectiveness of the Smith Predictor

NCT03073408 | Unknown

• 1 other identifier: 2017_
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The action of anesthetics such as propofol is not immediate after intravenous administration. Delay in pharmacodynamic effect of intravenous drugs is a commonly observed phenomenon in total intravenous anesthesia (TIVA). On the other hand, the measure of the clinical effect of propofol by EEG processed monitors like the bispectral index (BIS) also requires some processing time for the analysis of the recorded signal. Thus, the resulting BIS value provided by the monitor is affected by a delay. When a BIS based controller is used, the propofol infusion rates are defined using information of the BIS signal available. The delay in the BIS signal is an important issue as it can affect the performance of the controller. There are scarce contributions to address the delay in automatic administration of anesthesia. Our proposal to deal with the dead time in the control action of the hypnotic component of anesthesia is a proportional-integral (PI) algorithm with a Smith predictor. The aim of this study is to evaluate and compare the feasibility and effectiveness of a closed-loop control using the Smith predictor versus manual control for propofol administration guided by the bispectral index (BIS) in adults patients. The objective is to show that a closed loop control can be a useful tool to provide safe and effective intravenous anesthesia and that the use of specific controller for delay rejection is a reliable strategy.

Conditions

General Anesthesia

Keywords

Propofol; Bispectral index (BIS); Closed loop

Outcome Measures

Primary Outcomes (1)

• Evaluation of the performance of the 2 groups with the global score (GS).

  Global score is a calculated parameter which gives an idea of the overall performance of a closed-loop system. It is calculated as the sum of MDAPE and wobble divided by the fraction of time BIS was within ±10 of the target. The target BIS chosen will be 50. The GS is calculated according the formula: GS = (MDAPE + wobble)/ % of time with BIS between 40 and 60

  During anesthesia maintenance, approximately 9 hours

Secondary Outcomes (7)

• The percentage of time with BIS values within +/10 % of target BIS.

  During anesthesia maintenance, approximately 9 hours

• MDPE (median performance error)

  During anesthesia maintenance, approximately 9 hours

• MDAPE (median absolute performance error):

  During anesthesia maintenance, approximately 9 hours

• Wobble

  During anesthesia maintenance, approximately 9 hours

• Time to eyes opening

  30 minutes after the end of the anesthesia

Study Arms (2)

1: Manual control group

ACTIVE COMPARATOR

The propofol infusion rate is adjusted manually in a pump by the investigator to maintain BIS between 40 and 60. For this titration it is necessary continuous monitoring, clinical experience, and pharmacokinetic/pharmacodynamic knowledge.

Drug: Propofol

2: PI +Smith group

EXPERIMENTAL

The closed loop control automatically adjust propofol infusion rate guided by the feedback of the real value of BIS. The automatic system has to achieve a target BIS of 50 and maintain it between 40 and 60.

Drug: Propofol

Interventions

Propofol DRUG

Closed loop control for propofol administration guided by the BIS.

2: PI +Smith group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• years of age or older
• Classification of the American Society of Anesthesiologists (ASA) as I or II
• Elective surgical procedures requiring general anesthesia with an estimated duration \> 30 minutes

You may not qualify if:

• Pregnant women,
• Patients with neurological or psychiatric disorders
• Patients taking any medication known to influence the EEG and subsequently the BIS

Sponsors & Collaborators

• José Antonio Reboso Morales: lead
• University of La Laguna: collaborator

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 8, 2017
• Study Start: March 6, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)