Alteration of Temporal Organization of EEG Microstate Sequences During Propofol-induced Loss of Consciousness

NCT02125214 | Completed DMC

• 1 other identifier: Fractal-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Temporal dynamics of the EEG microstates show scale-free monofractal properties. This means that information is encoded in the same way at different scales. It may be postulated that these monofractal properties of the EEG microstate sequences constitute a necessary prerequisite of consciousness. We postulate that clinical variations of consciousness may also be linked to alterations of fractal properties of EEG microstates.

Conditions

Loss of Consciousness

Keywords

consciousness, anesthesia, electroencephalogram, microstate, long-range dependency

Outcome Measures

Primary Outcomes (1)

• EEG microstates

  Assess the alteration of temporal organization of EEG microstate sequences during propofol-induced loss of consciousness.

  45 minutes

Study Arms (1)

ASA 1-2

EXPERIMENTAL

ASA 1-2 patients 20-40 yr

Device: Target Controlled Infusion system (Orchestra Base Primea, Fresenius, France)

Interventions

Target Controlled Infusion system (Orchestra Base Primea, Fresenius, France) DEVICE

Intravenous induction with propofol using the pharmacokinetic model by Schnider et al. The initial cerebral concentration will be 0.5 µg ml-1, which will be increased stepwise by 1.0 µg ml-1 until 2.5 µg ml-1, and then by 0.5 µg ml-1 until loss of consciousness

ASA 1-2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients (age between 18 and 40 years)
• Right-handed
• American Society of Anesthesiology (ASA) status I-II
• Scheduled for elective surgery requiring a general anaesthetic
• Able to read and understand the information sheet and to sign and date the consent form.

You may not qualify if:

• Patients with significant cardio-respiratory or other end-organ disease (renal or hepatic disease influencing metabolism or elimination of study drugs).
• Patients with depression, neurological or psychiatry disorders.
• Dementia or inability to understand the study informed consent.
• Patients with a history of oesophageal reflux, hiatus hernia or any other condition requiring rapid sequence induction of anaesthesia.
• History of drug (opioids) or alcohol abuse.
• Patients with a body mass index \>30 kg m-2.
• Left handed patients
• History of allergy or hypersensitivity to propofol.

Sponsors & Collaborators

• Julien Maillard: lead
• University of Geneva, Switzerland: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, Canton of Geneva, 1206, Switzerland

Location

Related Publications (1)

• Britz J, Van De Ville D, Michel CM. BOLD correlates of EEG topography reveal rapid resting-state network dynamics. Neuroimage. 2010 Oct 1;52(4):1162-70. doi: 10.1016/j.neuroimage.2010.02.052. Epub 2010 Feb 24.

  PMID: 20188188 BACKGROUND

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Tramer, MD, DPhil

  University Hospitals of Geneva, Department of Anesthesiology

  STUDY DIRECTOR

• Julien Maillard, MD

  University Hospitals of Geneva, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

CH (1)