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Clinical Trials/NCT02624401
NCT02624401
Completed
Phase 4

The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)

University of Turku1 site in 1 country160 target enrollmentJanuary 2016

Overview

Phase
Phase 4
Intervention
Placebo
Conditions
Anesthesia
Sponsor
University of Turku
Enrollment
160
Locations
1
Primary Endpoint
Regional cerebral metabolism of glucose
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of the anesthetic (40 dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and metabolomics samples will be taken and analysed to find possible genetic factors explaining the variability in drug response and to find chemical fingerprints of acute drug effect.

Detailed Description

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. Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine acting through α2-agonism, with propofol and sevoflurane both mainly acting through the enhancement of gamma-aminobutyric acid (GABA) system, and with S-ketamine acting through N-methyl-D-aspartate (NMDA) receptor antagonism. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of either dexmedetomidine, propofol, S-ketamine or sevoflurane, or placebo while being imaged for cerebral metabolic rate of glucose (CMRglu). 40 subjects will receive dexmedetomidine, 40 subjects propofol, 20 subjects S-ketamine, 40 subjects sevoflurane and 20 subjects will receive placebo. Also genetic, immunological and metabolomics samples will be taken and analysed to find possible genetic factors explaining the variability in drug response and to find possible immunological and chemical fingerprints of acute drug effect.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
March 13, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harry Scheinin

Adjunct Professor

University of Turku

Eligibility Criteria

Inclusion Criteria

  • Age 18-30 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
  • Clinically significant previous cardiac arrhythmia / cardiac conduction impairment
  • Clinically significant abnormality in prestudy laboratory tests
  • Positive result in the drug screening test

Arms & Interventions

Placebo

Intravenous saline.

Intervention: Placebo

Dexmedetomidine

Intravenous dexmedetomidine using target controlled infusion.

Intervention: Dexmedetomidine

Propofol

Intravenous propofol using target controlled infusion.

Intervention: Propofol

S-ketamine

Intravenous S-ketamine using target controlled infusion.

Intervention: S-ketamine

Sevoflurane

Inhalational sevoflurane using target controlled inhalation.

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Regional cerebral metabolism of glucose

Time Frame: 40 min

Comparison of responsive and unresponsive subjects

Secondary Outcomes

  • Immunological effects(2 hours)
  • Gene expression(2 hours)
  • Psychological well-being(2 hours)
  • Dream report(1 hour)
  • EEG(1 hour)
  • Metabolomic effects(2 hours)

Study Sites (1)

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