The Neural Mechanisms of Anesthesia and Human Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-01-31

Brief Summary

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The explanation of consciousness poses one of the greatest challenges to science and philosophy in the 21st century. It remains unclear what consciousness is and how it emerges from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what happens in the brain when consciousness is lost and when it returns. During the study, a series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out on healthy male subjects to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with normal sleep and anesthetic agents dexmedetomidine and propofol.

First, various neurophysiological tools to separate consciousness, connectedness and responsiveness during normal sleep will be tested. The most suitable methods and subjects will be selected and then tested during anesthetic-induced sedation and loss of responsiveness (LOR). The anesthetics (dexmedetomidine or propofol) will be administered as target-controlled infusions (TCI) with step-wise concentration-increments until LOR is detected. Then, TCIs are repeated in the same subjects but adjusted according to the individual drug target concentrations sufficient for LOR, and a series of PET perfusion imaging measurements will be performed to obtain the brain activity information in various states of consciousness. The same subjects will then be imaged with PET for brain activity after sleep deprivation (awake), during various sleep stages and immediately after awakening. Finally, ten dexmedetomidine subjects will be given the drug once more, and functional MRI (fMRI) data will be collected at various states of consciousness before and during verbal and nonverbal vocalizations. EEG will be continuously collected in all sessions. The depth of anesthesia will be measured using quantitative EEG and bispectral index (BIS) monitoring.

The results may lead to the discovery of new and better objective indicators of the depth of anesthesia and consciousness, and new insights into the understanding of neural mechanisms behind drug-induced loss of consciousness and ultimately the mechanisms of action of (general) anesthetics as well as consciousness itself.

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Detailed Description

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(not needed)

Conditions

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Consciousness, Level Altered

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine

Intravenous dexmedetomidine using target controlled infusion

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Escalating concentrations until loss of responsiveness

Propofol

Intravenous propofol using target controlled infusion

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Escalating concentrations until loss of responsiveness

Interventions

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Dexmedetomidine

Escalating concentrations until loss of responsiveness

Intervention Type DRUG

Propofol

Escalating concentrations until loss of responsiveness

Intervention Type DRUG

Other Intervention Names

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Dexdor Propofol-Lipuro

Eligibility Criteria

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Inclusion Criteria

* Male
* Age 20-30 years
* Good general health i.e. American Society of Anesthesiologists (ASA) physical status I
* Fluent in Finnish language
* Right handedness
* Written informed consent
* Good sleep quality

Exclusion Criteria

* Chronic medication
* History of alcohol and/or drug abuse
* Strong susceptibility for allergic reactions
* Serious nausea in connection with previous anesthesia
* Strong susceptibility for nausea
* Any use of drugs or alcohol during the 48 hours preceding anesthesia
* Use of caffeine products 10-12 hours prior the study, 24 hours before sleep studies
* Smoking
* Clinically significant previous cardiac arrhythmia / cardiac conduction impairment
* Clinically significant abnormality in prestudy laboratory tests
* Positive result in the drug screening test
* Blood donation within 90 days prior to the study
* Participation in any medical study with an experimental drug or device during the preceding 60 days
* The study subject has undergone a prior PET or SPECT study
* Any contraindication to magnetic resonance imaging (MRI)
* Hearing impairment
* Detected unsuitability based on initial electrophysiological measurements
* Detected unsuitability based on MRI scanning results
* Sleep disorder or severe sleep problem

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes