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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03839784
Other study ID # 55169
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date August 30, 2024

Study information

Verified date November 2023
Source Stanford University
Contact Samantha M Gaston, BS
Phone 650-714-2542
Email sgaston@stanford.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - At least 65 years old (inclusive) - Non cardiac general elective surgery - General anesthesia is expected for 2+ hours Exclusion Criteria: - Alzheimer's - Dementia - Parkinson's - History of neurodegenerative diseases - Medication for depression (ie. Benzodiazepines) - Alcoholism - Discretion of PI

Study Design


Intervention

Combination Product:
Neurocognition Interventions
EEG, Neurocognitive Battery Testing, and Immune Profiles

Locations

Country Name City State
United States Stanford Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Neurocognitive Disorders Neurocognitive Assessment Battery 3 years
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