Cognitive ReserveNCT06490588
Use of Sevoflurane to Test Concept of Cognitive Reserve
An observational study of Cognitive Reserve and BIS, run by Los Angeles General Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Reserve, BIS
- What is being tested?
- sevoflurane
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA I or II
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative BIS variability
Measured: 360 minutes
Secondary outcomes (1)
time to recovery
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Los Angeles General Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jody Chou, Los Angeles General Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490588
- Sponsor's protocol ID
- HS-22-00653
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31120896
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06490588
- Acronym / sponsor ID
- HS-22-00653
- Conditions
- Cognitive Reserve, BIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Los Angeles General Medical CenterUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I or II
Key inclusion criteria (8 listed)
- - 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
Key exclusion criteria (8 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevofluraneNo intervention | Other | – |
Primary outcome
intraoperative BIS variability
Time frame: 360 minutes
1 secondary outcome
time to recovery
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 31120896Hernaiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Reserve and BIS, run by Los Angeles General Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jody Chou, MD, MPH (949-310-7024, cchou@dhs.lacounty.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative BIS variability (time frame: 360 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.