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Completed

NCT Number: NCT02706665

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Canarias

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEDline monitor

Other

The SEDline monitor gives us the Patient State Index (PSI), a dimensionless number within a range of 0 to100.

Primary outcomes

  1. 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

    Time frame: During general anaesthesia in the operating room for a scheduled surgery.

    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.

Secondary outcomes

  1. Time from discontinuation of intravenous agents to open eyes to order

    Time frame: In the operation room at the end of surgery

    It will be measured with a chronometer

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Collaborators

  • Masimo Corporation

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Mar 11, 2016
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.