Use of Sevoflurane to Test Concept of Cognitive Reserve
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
1 other identifier
observational
70
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 8, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedJuly 8, 2024
June 1, 2024
7 months
June 25, 2024
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
intraoperative BIS variability
360 minutes
Secondary Outcomes (1)
time to recovery
120 minutes
Interventions
No intervention
Eligibility Criteria
ASA I or II
You may qualify if:
- \- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31120896BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician Specialist
Study Record Dates
First Submitted
June 25, 2024
First Posted
July 8, 2024
Study Start
September 1, 2024
Primary Completion
April 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
July 8, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share