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

August 3, 2015 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27709
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of cerebrospinal fluid tau to amyloid beta
Time Frame: twenty four hours after the induction of anesthesia
twenty four hours after the induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
the relationship between anesthetic exposure and CSF biomarker changes
Time Frame: up to 24 hrs after induction of anesthesia
up to 24 hrs after induction of anesthesia
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
up to 24 hrs after induction of anesthesia
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
up to 24 hrs after induction of anesthesia
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
up to 24 hrs after induction of anesthesia
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
up to 24 hours after induction of anesthesia
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
up to 24 hours after induction of anesthesia
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
up to 24 hours after induction of anesthesia
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
up to 24 hours after induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (ESTIMATE)

July 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00030861

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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