Use of Sevoflurane to Test Concept of Cognitive Reserve

Not yet recruiting

• Conditions: Cognitive Reserve; BIS

• Registration Number: NCT06490588
• Lead Sponsor: Los Angeles General Medical Center

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 individual's ability to resist damage to the brain and is thought to be associated with an individual's 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 individual's 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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Study Start: 2024-09
• Primary Completion: 2025-04
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• • Minimal completion of high-school education
• Adult patient < 85 years of age
• No prior known history of cognitive/brain disease
• ASA class I-II
• Undergoing general anesthesia with sevoflurane for maintenance anesthesia
• Same-day surgery
• Elective procedures
• No prior history of cardiac disease

Exclusion Criteria

• • History of chronic pain
• Perioperative use of anesthetic agents other than propofol, fentanyl, dilaudid, and sevoflurane
• History of alcohol/substance druge abuse
• Psychiatric history
• Morbid history
• History of OSA, stroke, or TIA
• Blindness
• Deafness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intraoperative BIS variability	360 minutes

Secondary Outcome Measures

Name	Time	Method
time to recovery	120 minutes