Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03839784
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 47.9
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline; Cognitive Change; Cognitive Impairment; Postoperative Delirium; Anesthesia; Reaction; Anesthesia; Adverse Effect	Combination Product: Neurocognition Interventions

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Aug 30, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Neurocognitive Assessment Arm	Combination Product: Neurocognition Interventions; EEG, Neurocognitive Battery Testing, and Immune Profiles

Outcome Measures

Primary Outcome Measures

1. Postoperative Neurocognitive Disorders [3 years]

   Neurocognitive Assessment Battery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Medical Center	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: David Drover, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David R. Drover, Professor of Anesthesiology, Stanford University
• ClinicalTrials.gov Identifier: NCT03839784
• Other Study ID Numbers: 55169
• First Posted: Feb 15, 2019
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Delirium; Cognitive Dysfunction

Study Results

No Results Posted as of May 11, 2022