RecruitingNot Applicable

Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

Turkey (Türkiye)60 participantsStarted 2026-05-01

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery * Planned use of general anesthesia * Written informed consent Exclusion Criteria: * Preexisting neurological disease * Use of medications affecting Electroencephalography (e.g., antiepileptics) * Severe hepatic dysfunction * Emergency surgery * Inadequate signal quality for anesthesia depth monitoring

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) Under Normothermic and Hypothermic Conditions

Timeframe: Intraoperative (during cardiopulmonary bypass at predefined time points)

Trial details

NCT IDNCT07508579

SponsorSakarya University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01

Contact for this trial

AHMET R DOĞAN, M.D

+905427988070 a.ridvandogan@gmail.com

View on ClinicalTrials.gov More Cardiopulmonary Bypass trials