Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia

General Anesthesia Clinical Trial

— MAD-PIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640275
• Other study ID #: Pro00030861
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2012
• Last updated: August 3, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• General Anesthesia

Intervention

Drug:
• Propofol
patients randomized to the propofol arm of the study will receive general anesthesia with propofol
• Isoflurane
patients randomized to the isoflurane arm of the study will receive general anesthesia with isoflurane

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of cerebrospinal fluid tau to amyloid beta		twenty four hours after the induction of anesthesia	No
Secondary	the relationship between anesthetic exposure and CSF biomarker changes		up to 24 hrs after induction of anesthesia	No
Secondary	the relationship between anesthetic exposure and CSF biomarker changes, and demographics (age, gender, and race)		up to 24 hrs after induction of anesthesia	No
Secondary	the relationship between CSF biomarker changes and serum markers of metabolic and/or inflammatory status		up to 24 hrs after induction of anesthesia	No
Secondary	the relationship between anesthetic exposure and biomarker changes and serum markers of metabolic and/or inflammatory status		up to 24 hrs after induction of anesthesia	No
Secondary	the relationship between anesthetic exposure and biomarker changes and neuroimaging results obtained as dictated by routine standard of care		up to 24 hours after induction of anesthesia	No
Secondary	the relationship between anesthetic exposure and biomarker changes and depth of anesthesia, based on average BIS (bispectral index) monitoring signal		up to 24 hours after induction of anesthesia	No
Secondary	the relationship between anesthetic exposure and biomarker changes and the time of day that surgery is performed		up to 24 hours after induction of anesthesia	No
Secondary	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		up to 24 hours after induction of anesthesia	No