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Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia

NCT01640275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-08-04

No results posted yet for this study

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.

Conditions

  • General Anesthesia

Interventions

DRUG

Propofol

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

DRUG

Isoflurane

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

Sponsors & Collaborators

Principal Investigators

  • Miles Berger, MD, PhD · Duke University Medical Center, Department of Anesthesiology

  • Michael L James, MD · Duke University Medical Center, Department of Anesthesiology

  • David McDonagh, MD · Duke University Medical Center, Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640275 on ClinicalTrials.gov