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

Duke University logo

Duke University

Status and phase

Completed
Phase 1

Conditions

General Anesthesia

Treatments

Drug: Isoflurane
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT01640275
Pro00030861

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups

Propofol based intravenous anesthesia
Active Comparator group
Description:
patients will receive propofol based intravenous anesthesia
Treatment:
Drug: Propofol
Isoflurane Based Inhaled Anesthesia
Experimental group
Description:
patients will receive isoflurane based inhaled anesthesia
Treatment:
Drug: Isoflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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