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NCT Number: NCT06490588

Use of Sevoflurane to Test Concept of Cognitive Reserve

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sevoflurane

Other

No intervention

Primary outcomes

  1. intraoperative BIS variability

    Time frame: 360 minutes

Secondary outcomes

  1. time to recovery

    Time frame: 120 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Jody Chou, MD, MPH

CONTACT

[email protected]

949-310-7024

Sponsors and collaborators

Lead sponsor

Los Angeles General Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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