Monitoring of Hypnosis State During General Anesthesia With Propofol by Patient State Index From SEDLine®

Modelling Pharmacokinetic/Pharmacodynamic of Propofol Based on PSI Values From the SEDline®

The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.

Study Overview

• Status: Completed
• Conditions: Hypnotic Effect
• Intervention / Treatment: Other: SEDline monitor

Detailed Description

Introduction:

There is a large intra-and interindividual variability in the effect of propofol. To deal with this problem, a real-time monitoring and therefore a more accurate titration of anesthetic agents is proposed. Brain function monitors based on a processed analysis of EEG (Electroencephalogram) can help to control pharmacodynamic effects of hypnotic agents. PSI values provide a measurement of the hypnotic effect of propofol. It will be observed an inverse correlation between the propofol infusion rate and the PSI value.

Objectives:

To design a computer program to record simultaneously the propofol infusion rate, PSI and Electromyogram (EMG).

To study the correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.

To obtain a mathematical model of the system from data recorded with different identification techniques.

Methods:

A group of patients scheduled for surgery under a standard total intravenous anesthesia (TIVA) with propofol and remifentanil will be recruited. The hypnotic effect of propofol will be monitored with the PSI from a SEDline monitor continuously. All anesthetic doses and their changes fall within conventional dosing.

The procedure for recording data and obtaining the pharmacokinetics/pharmacodynamics (PK / PD) model will be connecting a SEDLine® monitor to a laptop with an original program developed by members of our team. The program automatically stores the infusion rate of propofol (mg/kg/h) and the simultaneous values of PSI and frontal EMG. Graphics and data collected will be explored with various systems of techniques for pattern recognition in order to get the best fit to define a mathematical model of the dose of propofol and PSI values. A subsequent computer analysis with MATLAB® will estimate the correlation between the infusion of propofol infusion rate and PSI values.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario de Canarias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients undergoing a surgery procedure with general anesthesia.

Description

Inclusion Criteria:

• American Society of Anesthesiologists classification of I, II, or III
• Patient signed an informed consent

Exclusion Criteria:

• Patients with prior neurological disease, epilepsy or stroke.
• Patients who are receiving drug therapy that may alter processed EEG monitoring and decrease the PSI accuracy.
• American Society of Anesthesiologists classification IV or higher

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG processed will be measured by non invasive adhesive electrodes on the skin of the forehead's patient. A disposable sensor connected with a SEDLine provides de PSI index	The values from the SEDLine ® monitor inversely correlate with the rate of infusion of propofol. Changes in that velocity correspond to changes in the effect site (CNS) and are related to the PSI values displayed in the monitor.	During general anaesthesia in the operating room for a scheduled surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from discontinuation of intravenous agents to open eyes to order	It will be measured with a chronometer	In the operation room at the end of surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias
• Collaborators: Masimo Corporation
• Investigators: Principal Investigator: Jose Antonio Reboso Morales, MD, PhD, Hospital Universitario de Canarias

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (ESTIMATE): March 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Propofol; Anesthetics; Electroencephalography; SEDline monitor
• Other Study ID Numbers: 2013_10