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

NCT02624401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-03-27

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Unconsciousness

Interventions

DRUG

Dexmedetomidine

Intravenous infusion

DRUG

Propofol

Intravenous infusion

DRUG

S-ketamine

Intravenous infusion

DRUG

Sevoflurane

Inhalation

DRUG

Placebo

Intravenous infusion of saline (Ringer's Acetate)

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • Yale University

    collaborator OTHER
  • University of Helsinki

    collaborator OTHER
  • University of Turku

    lead OTHER

Principal Investigators

  • Harry Scheinin, MD · Turku PET Centre, University of Turku, Turku, Finland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-03-13
Completion
2017-03-13

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624401 on ClinicalTrials.gov