Use of Sevoflurane to Test Concept of Cognitive Reserve

NCT ID: NCT06490588

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

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.

Conditions

Cognitive Reserve; BIS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

sevoflurane

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Los Angeles General Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jody Chou

Physician Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jody Chou, MD, MPH

Role: CONTACT

cchou@dhs.lacounty.gov

949-310-7024

References

Hernaiz Alonso C, Tanner JJ, Wiggins ME, Sinha P, Parvataneni HK, Ding M, Seubert CN, Rice MJ, Garvan CW, Price CC. Proof of principle: Preoperative cognitive reserve and brain integrity predicts intra-individual variability in processed EEG (Bispectral Index Monitor) during general anesthesia. PLoS One. 2019 May 23;14(5):e0216209. doi: 10.1371/journal.pone.0216209. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31120896 (View on PubMed)

Other Identifiers

HS-22-00653

Identifier Type: -

Identifier Source: org_study_id