Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

Recruiting now

Conditions studied: Cardiopulmonary Bypass, Hypothermia; Anesthesia, Depth of Anesthesia Monitoring

In brief

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

Key facts

Study ID

NCT07508579

Run by

Sakarya University

People needed

60

Starts

2026-05-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery
• Planned use of general anesthesia
• Written informed consent

You may not qualify if…

• Preexisting neurological disease
• Use of medications affecting Electroencephalography (e.g., antiepileptics)
• Severe hepatic dysfunction
• Emergency surgery
• Inadequate signal quality for anesthesia depth monitoring

Where it is running

• Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation — Sakarya, Serdivan, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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