Correlation and agreement between the bispectral index vs. state entropy during hypothermic cardio-pulmonary bypass.
P Meybohm, M Gruenewald, J Höcker...
https://pubmed.ncbi.nlm.nih.gov/19839944Actively Recruiting
Led by Sakarya University · Updated on 2026-05-11
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are evaluating how hypothermia affects the relationship between two brain monitoring indices, the Bispectral Index (BIS) and Patient State Index (PSI), during cardiac surgery involving cardiopulmonary bypass in adult patients. This observational study focuses on whether the correlation between these indices changes between normal body temperature and lowered body temperature phases, and how they respond as temperature decreases. The study aims to clarify the impact of hypothermia on brain activity monitoring during surgery, which may influence anesthetic management. Adult patients undergoing elective on-pump coronary artery bypass surgery will receive standard general anesthesia and surgical care. BIS and PSI sensors will be applied before anesthesia induction, and both indices will be monitored simultaneously during surgery. Data will be recorded at specific time points representing normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass, without altering routine clinical management. Participants will be monitored continuously with BIS and PSI devices during surgery, with data collection focused on temperature-based phases of cardiopulmonary bypass. Researchers will analyze the difference in correlation between BIS and PSI at normal and lowered temperatures, changes per degree Celsius during cooling and rewarming, and agreement in clinical depth-of-anesthesia categories. The study involves only intraoperative monitoring and assessment during the surgery period.
CONDITIONS
Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgery (several hours)
Participants undergo elective on-pump coronary artery bypass grafting surgery during which Bispectral Index (BIS) and Patient State Index (PSI) are monitored simultaneously at predefined time points throughout normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass.
1 surgical procedure visit (in-person)
Duration - Follow-up as per routine clinical care
Participants are observed postoperatively as part of routine care; data collection focuses on intraoperative monitoring outcomes.
Visits as per routine clinical care
Total: 1 location
1
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
Sakarya, Serdivan, Turkey (Türkiye)
Actively Recruiting
A
AHMET R DOĞAN, M.D
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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P Meybohm, M Gruenewald, J Höcker...
https://pubmed.ncbi.nlm.nih.gov/19839944Alessandro Belletti, Dong-Kyu Lee, Fumitaka Yanase...
https://pubmed.ncbi.nlm.nih.gov/37469479