NCT03839784

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Sep 2020Aug 2030

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

February 11, 2019

Last Update Submit

April 21, 2026

Conditions

Cognitive DeclineCognitive ChangeCognitive ImpairmentPostoperative DeliriumAnesthesia; ReactionAnesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (1)

  • Postoperative Neurocognitive Disorders

    Neurocognitive Assessment Battery

    3 years

Study Arms (1)

Neurocognitive Assessment Arm

Combination Product: Neurocognition Interventions

Interventions

Neurocognition InterventionsCOMBINATION_PRODUCT

EEG, Neurocognitive Battery Testing, and Immune Profiles

Neurocognitive Assessment Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stanford Hospital geriatric patients having surgery.

You may qualify if:

  • At least 65 years old (inclusive)
  • Non cardiac general elective surgery
  • General anesthesia is expected for 2+ hours

You may not qualify if:

  • Alzheimer's
  • Dementia
  • Parkinson's
  • History of neurodegenerative diseases
  • Medication for depression (ie. Benzodiazepines)
  • Alcoholism
  • Discretion of PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionEmergence Delirium

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • David Drover, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

September 1, 2020

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

August 30, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)