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OpenTrials
Completed

NCT Number: NCT03361605

Neuroimaging of Anesthetic Modulation of Human Consciousness

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have a body mass index (BMI) less than 30.
  • 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;
  • Contraindications to neuroimaging methods;
  • Inability or unwilling to fast, or withhold food and liquid intake, for 8 hours prior to your scheduled study visit.
  • Unwilling to abstain from alcohol use for 24 hours prior to your scheduled study visit.
  • History of drug use, or have a positive drug screen.
  • Tattoos on the head or neck region - all other tattoos are subject to determination by investigators.
  • Any impairment, activity or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.

Treatment and study plan

Propofol

Drug

Propofol administration

Primary outcomes

  1. 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

  1. Change From Baseline in Squeeze Pressure

    Time frame: Baseline to 90 minutes

    Measurements of the force of participants' hand squeezing on a rubber ball in response to instructions. Change = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2017
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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