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NCT Number: NCT01640275

Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia

Previous work in animal models suggests that inhalational anesthetic agents may accelerate Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in humans. Here, the investigators propose to measure Alzheimer's disease-related neural markers in the cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing neurosurgical procedures that require lumbar drain placement. Patients will be randomized to either receive inhalation anesthesia with isoflurane or intravenous anesthesia with propofol.

CSF and blood samples will each be collected at the induction of anesthesia, and then again ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and other Alzheimer's disease-associated markers; blood samples will be assayed for serum inflammatory markers and used for genotyping studies. These studies should clarify the effect of common anesthetic agents on Alzheimer's disease related neural markers.

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Key information

Conditions

General Anesthesia Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27709, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 and above
  • seen in neurosurgical clinic, and scheduled for operative aneurysm repair or other neurosurgical procedure necessitating lumbar drain placement.
  • ability to speak English.
  • ability to understand consent forms, and to give informed consent.

Exclusion criteria

  • age less than 18
  • lumbar drain is not placed
  • not eligible for one of the anesthetics (inhaled isoflurane or IV propofol)
  • inmate of a correctional facility (i.e. prisoners).
  • pregnancy. Pregnancy is ruled out as standard of care before cranial surgery, based on clinical history and/or HCG testing

Treatment and study plan

Propofol

Drug

patients randomized to the propofol arm of the study will receive general anesthesia with propofol

Isoflurane

Drug

patients randomized to the isoflurane arm of the study will receive general anesthesia with isoflurane

Primary outcomes

  1. Ratio of cerebrospinal fluid tau to amyloid beta

    Time frame: twenty four hours after the induction of anesthesia

Secondary outcomes

  1. the relationship between anesthetic exposure and CSF biomarker changes

    Time frame: up to 24 hrs after induction of anesthesia

  2. the relationship between anesthetic exposure and CSF biomarker changes, and demographics (age, gender, and race)

    Time frame: up to 24 hrs after induction of anesthesia

  3. the relationship between CSF biomarker changes and serum markers of metabolic and/or inflammatory status

    Time frame: up to 24 hrs after induction of anesthesia

  4. the relationship between anesthetic exposure and biomarker changes and serum markers of metabolic and/or inflammatory status

    Time frame: up to 24 hrs after induction of anesthesia

  5. the relationship between anesthetic exposure and biomarker changes and neuroimaging results obtained as dictated by routine standard of care

    Time frame: up to 24 hours after induction of anesthesia

  6. the relationship between anesthetic exposure and biomarker changes and depth of anesthesia, based on average BIS (bispectral index) monitoring signal

    Time frame: up to 24 hours after induction of anesthesia

  7. the relationship between anesthetic exposure and biomarker changes and the time of day that surgery is performed

    Time frame: up to 24 hours after induction of anesthesia

  8. the relationship between anesthetic exposure and biomarker changes with genetic polymorphisms in ApoE (apolipoprotein E) and other genes related to inflammation, metabolism, brain function and/or Alzheimer's disease

    Time frame: up to 24 hours after induction of anesthesia

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Effect of Isoflurane Versus Propofol Anesthesia on Alzheimers Disease CSF Markers

Acronym: MAD-PIA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2012
Registry last updated
Aug 4, 2015

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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