Viewing Study NCT06490588



Ignite Creation Date: 2024-07-17 @ 11:10 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06490588
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-08
First Post: 2024-06-25

Brief Title: Use of Sevoflurane to Test Concept of Cognitive Reserve
Sponsor: Los Angeles General Medical Center
Organization: Los Angeles General Medical Center

Study Overview

Official Title: The Use of Sevoflurane to Test the Concept of Intra-individual Variability in Bispectral Index Monitor and Cognitive Reserve by Examining Time to Emergence and Recovery
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Previous pilot study had demonstrated a correlation between cognitive reserve and BIS variability during steady state of anesthesia This study we intend to evaluate the association between BIS variability and emergence and recovery time from anesthesia
Detailed Description: Cognitive reserve CR refers to an individuals ability to resist damage to the brain and is thought to be associated with an individuals education cognitive stimulation and physical activity Those with greater CR have protection against degenerative brain changes such as dementia Currently CR is evaluated through a host of proxy tests such as questionnaires aimed to assess various aspects of cognitive function These ways of measuring CR test directly only on an individuals ability to perform certain tasks when the brain is in its unchallenged state However this approach poses significant limitations since CR is developed as a concept representing the physiological brain reserve that helps counter the clinical manifestation of a diseased or challenged brain A method that simulates a state of challenged brain during CR measurement may provide a more precise assessment of CR

Anesthetic agents are known to reversibly alter brain function resulting in a state of sedation or amnesia Whether this way of brain challenge can provide information on CR is unknown

A previous study showed preliminary evidence that patients with higher CR correlates with less variability in bispectral index BIS during steady state of anesthesia with inhaled anesthetic sevoflurane 1 While the result of this study is encouraging further study is needed to develop the concept of using anesthetic agents to evaluate CR Specifically a study investigating the correlation between intraoperative BIS variability and timing of clinical recovery from anesthesia will be necessary This will further elucidate how to use anesthetic agent for the evaluation of CR

Building on the previous study result and the concept that higher CR means higher resilience against brain function in a challenged state we hypothesize that less intraoperative BIS variability correlates with shorter recovery time from anesthesia

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None