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Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia (MAD-PIA)

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ClinicalTrials.gov Identifier: NCT01640275
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Propofol Drug: Isoflurane Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of Isoflurane Versus Propofol Anesthesia on Alzheimers Disease CSF Markers
Study Start Date : March 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Propofol based intravenous anesthesia
patients will receive propofol based intravenous anesthesia
 Drug: Propofol
patients randomized to the propofol arm of the study will receive general anesthesia with propofol
Experimental: Isoflurane Based Inhaled Anesthesia
patients will receive isoflurane based inhaled anesthesia
 Drug: Isoflurane
patients randomized to the isoflurane arm of the study will receive general anesthesia with isoflurane


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of cerebrospinal fluid tau to amyloid beta [ Time Frame: twenty four hours after the induction of anesthesia ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640275


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27709
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Miles Berger, MD, PhD Duke University Medical Center, Department of Anesthesiology
Principal Investigator: Michael L James, MD Duke University Medical Center, Department of Anesthesiology
Principal Investigator: David McDonagh, MD Duke University Medical Center, Department of Anesthesiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01640275    
Other Study ID Numbers: Pro00030861
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: March 2015
Keywords provided by Duke University:
General Anesthesia
Alzheimers Disease
Cognitive decline
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Propofol
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation