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NCT07508579

Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

Sponsor: Sakarya University

View on ClinicalTrials.gov

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

Official title: Effect of Hypothermia on the Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) During Cardiopulmonary Bypass

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-05-01

Completion Date

2026-12-31

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

OTHER

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.