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Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

NCT07508579 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-05-11

No results posted yet for this 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

Conditions

  • Cardiopulmonary Bypass
  • Hypothermia; Anesthesia
  • Depth of Anesthesia Monitoring

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.

Sponsors & Collaborators

  • Sakarya University

    lead OTHER

Principal Investigators

  • AYÇA TAŞ TUNA, Professor, M.D. · Sakarya University Faculty of Medicine

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-08-01
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07508579 on ClinicalTrials.gov