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NCT07508579
Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass
Conditions: Cardiopulmonary Bypass, Hypothermia; Anesthesia, Depth of Anesthesia Monitoring
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 60
Sponsor: Sakarya University
Location: Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation Sakarya Serdivan
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
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery
* Planned use of general anesthesia
* Written informed consent
Exclusion Criteria:
* Preexisting neurological disease
* Use of medications affecting Electroencephalography (e.g., antiepileptics)
* Severe hepatic dysfunction
* Emergency surgery
* Inadequate signal quality for anesthesia depth monitoring
Source: ClinicalTrials.gov (NCT07508579). StuddyBuddy aggregates publicly available trial information.