Cognitive Outcomes and Neuroimages Associated With Anesthesia-Related EEG Signatures

NCT03442179 | Unknown

• 1 other identifier: 2017P000413
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we propose to evaluate the relationship between the alpha oscillation dynamics and the signals derived from the brain images related to brain aging.

Conditions

Elderly; General Anesthesia

Keywords

Aging; Anesthesia; EEG monitoring; Burst suppression

Outcome Measures

Primary Outcomes (3)

• Postoperative Delirium Incidence

  postoperative delirium will be assessed using 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM)

  on postoperative day 1

• Postoperative Cognitive Decline

  postoperative cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)

  one week before the surgery and postoperative day 7

• Intraoperative Burst Suppression Time

  we will use the EEG data recorded during the surgical procedure to calculate time spent in burst suppression

  during the surgical procedure under general anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

45 subjects (male and female) aged 65 and above scheduled for open or laparoscopic general surgical procedures under general anesthesia

You may qualify if:

• years old or above (male and female)
• American Society of Anesthesiologists (ASA) physical status classification of I, II or III.
• Candidates scheduled for open or laparoscopic general surgical procedures under general anesthesia
• No cognitive impairment base on Telephone Interview for Cognitive Status (TICS)
• Fluency in English Language

You may not qualify if:

• Prior diagnosis of dementia
• Prior diagnosis of Alzheimer's Disease
• Prior history of psychiatric or neurological diseases including:
• Schizophrenia
• Parkinsonism
• Epilepsy or seizure
• Brain injury
• Brain tumors/metastases
• Encephalitis
• Stroke, CVA, TIA
• Drug or alcohol abuse:
• Any history of IV drug abuse
• Alcohol/drug (non-IV) abuse \<10 years
• Language impairment
• Hearing or visual impairment

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (37)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to assess inflammatory markers.

Study Officials

• Patrick L. Purdon, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 22, 2018
• Study Start: February 13, 2019
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)