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

Hypnotic Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706665
• Other study ID #: 2013_10
• Status: Completed
• Start date: December 2015
• Est. completion date: May 2018

Study information

• Verified date: March 2016
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypnotic Effect

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias	Masimo Corporation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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