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Clinical Trials/NCT03361605
NCT03361605
Completed
Phase 4

Neuroimaging of Anesthetic Modulation of Human Consciousness

University of Michigan1 site in 1 country30 target enrollmentApril 12, 2017
ConditionsHealthy
InterventionsPropofol

Overview

Phase
Phase 4
Intervention
Propofol
Conditions
Healthy
Sponsor
University of Michigan
Enrollment
30
Locations
1
Primary Endpoint
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study's purpose is to see if mental functions take place during different levels of anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance Imaging, or "brain imaging") shows areas in the brain involved in thinking at different depths of anesthesia.

Detailed Description

Administering anesthetic drugs to suppress consciousness is an imperatively important step in major surgical operations. Yet the neurobiological mechanisms that underlie loss of consciousness under general anesthesia remain elusive. Despite advancements in understanding the molecular, synaptic, and cellular effects of anesthetics, the large-scale, systems-level modulation of neuronal processes that support conscious cognitive functions is incompletely understood. While profound decreases in global and regional brain metabolism, blood flow, and functional connectivity have been reported, these changes often fail to correlate with the loss and return of consciousness. To date, there is no "consciousness meter" or "gold standard" to objectively assess and monitor the level of consciousness under general anesthesia. Several studies suggest that residual cognitive functions may not completely vanish under general anesthesia; however, the level and complexity of residual information processing in the anesthetized brain remains unknown. Finally, the neurobiological mechanisms that govern anesthesia induction and emergence appear to be partially different, but the relevance of these differences to the modulation of the state of consciousness is unclear.

Registry
clinicaltrials.gov
Start Date
April 12, 2017
End Date
July 12, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anthony G Hudetz

Professor of Anesthesiology

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Must have a body mass index (BMI) less than
  • Must be right handed
  • Must be English speaking
  • Must be capable of giving written informed consent.
  • Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.

Exclusion Criteria

  • History of obstructive sleep apnea;
  • History of a difficult airway with a previous anesthetic;
  • History of neurological disorders;
  • Hypertension or other cardiovascular abnormalities;
  • Pulmonary hypertension or other pulmonary abnormalities;
  • Gastroesophageal reflux disease (GERD) or heartburn;
  • History of significant head injury with loss of consciousness;
  • Learning disability or other developmental disorder;
  • Allergic reactions to eggs;
  • Pregnant or nursing mothers;

Arms & Interventions

Propofol Administration

Intervention: Propofol

Outcomes

Primary Outcomes

Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation

Time Frame: Baseline to 90 minutes

Change = BOLD Response During Sedation - BOLD Response During Baseline

Secondary Outcomes

  • Change From Baseline in Squeeze Pressure(Baseline to 90 minutes)

Study Sites (1)

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