Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia

Phase 1

Completed

• Conditions: General Anesthesia
• Interventions: Drug: Propofol; Drug: Isoflurane

• Registration Number: NCT01640275
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol based intravenous anesthesia	Propofol	patients will receive propofol based intravenous anesthesia
Isoflurane Based Inhaled Anesthesia	Isoflurane	patients will receive isoflurane based inhaled anesthesia

Primary Outcome Measures

Name	Time	Method
Ratio of cerebrospinal fluid tau to amyloid beta	twenty four hours after the induction of anesthesia

Secondary Outcome Measures

Name	Time	Method
the relationship between CSF biomarker changes and serum markers of metabolic and/or inflammatory status	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	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	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	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	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	up to 24 hours after induction of anesthesia
the relationship between anesthetic exposure and CSF biomarker changes	up to 24 hrs after induction of anesthesia
the relationship between anesthetic exposure and CSF biomarker changes, and demographics (age, gender, and race)	up to 24 hrs after induction of anesthesia

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States