RecruitingNCT07508579

Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

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


Sponsor

Sakarya University

Enrollment

60 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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

Exclusion Criteria5

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

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Interventions

OTHERSimultaneous 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.


Locations(1)

Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

Sakarya, Serdivan, Turkey (Türkiye)

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NCT07508579


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