Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

Condition(s) studied

Investigational drug(s) / intervention(s)

Simultaneous BIS and PSI Monitoring: This observational study does not involve any experimental intervention. All participants will receive standard anesthesia and surgical care according to institutional protocols. The study focuses on simultaneous intraoperative monitoring using Bispectral Index (BIS) and Patient State Index (PSI) devices. Sensors for both monitors will be applied prior to induction of anesthesia, and values will be recorded at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass. No changes will be made to routine clinical management, and all treatments will be determined by the attending anesthesiologist.

Study 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

Primary outcome measure(s)

• Difference in Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) Under Normothermic and Hypothermic Conditions — Intraoperative (during cardiopulmonary bypass at predefined time points)
  The primary outcome is the difference in Pearson correlation coefficients between BIS and PSI measured at predefined normothermic (36°C) and hypothermic (32°C) phases during cardiopulmonary bypass. Correlation coefficients will be calculated separately for each phase and compared using Fisher z-transformation to determine whether hypothermia alters the relationship between these indices.

Trial sites (1)

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