Clinical trial NCT02706665: Monitoring of Hypnosis State During General Anesthesia With Propofol by Patient State Index From SEDLine®
Official title: Modelling Pharmacokinetic/Pharmacodynamic of Propofol Based on PSI Values From the SEDline®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypnotic Effect
Keywords: Anesthetics
Propofol
Electroencephalography
SEDline monitor
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2016-03-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients undergoing a surgery procedure with general anesthesia.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: During general anaesthesia in the operating room for a scheduled surgery.
Secondary outcomes:
measure: Time from discontinuation of intravenous agents to open eyes to order
timeFrame: In the operation room at the end of surgery
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Jose Antonio Reboso Morales, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: