Clinical Trial

Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

Recruiting
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Record status
This record was last updated May 11, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass. The main questions it aims to answer are: Does the correlation between Bispectral Index (BIS) and Patient State Index (PSI) change between normothermic and hypothermic phases during cardiopulmonary bypass? How do BIS and PSI values change in response to decreasing body temperature? Participants will: Undergo standard general anesthesia for elective on-pump coronary artery bypass surgery Be monitored simultaneously with BIS and PSI devices during surgery Have data recorded at predefined temperature-based time points during cardiopulmonary bypass
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-12
Trial Details
NCT Number NCT07508579
Lead Sponsor Sakarya University
Conditions Cardiopulmonary Bypass, Hypothermia; Anesthesia, Depth of Anesthesia Monitoring
Enrollment 60 participants
Start Date 2026-05-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-11