Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07508579

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

Led by Sakarya University · Updated on 2026-05-11

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how hypothermia affects the relationship between two brain monitoring indices, the Bispectral Index (BIS) and Patient State Index (PSI), during cardiac surgery involving cardiopulmonary bypass in adult patients. This observational study focuses on whether the correlation between these indices changes between normal body temperature and lowered body temperature phases, and how they respond as temperature decreases. The study aims to clarify the impact of hypothermia on brain activity monitoring during surgery, which may influence anesthetic management. Adult patients undergoing elective on-pump coronary artery bypass surgery will receive standard general anesthesia and surgical care. BIS and PSI sensors will be applied before anesthesia induction, and both indices will be monitored simultaneously during surgery. Data will be recorded at specific time points representing normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass, without altering routine clinical management. Participants will be monitored continuously with BIS and PSI devices during surgery, with data collection focused on temperature-based phases of cardiopulmonary bypass. Researchers will analyze the difference in correlation between BIS and PSI at normal and lowered temperatures, changes per degree Celsius during cooling and rewarming, and agreement in clinical depth-of-anesthesia categories. The study involves only intraoperative monitoring and assessment during the surgery period.

CONDITIONS

Brief Title

Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled for elective on-pump coronary artery bypass grafting surgery
  • Planned use of general anesthesia
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Preexisting neurological disease
  • Use of medications affecting electroencephalography, such as antiepileptics
  • Severe liver dysfunction
  • Emergency surgery
  • Poor signal quality for anesthesia depth monitoring during surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intraoperative Monitoring

Duration - Duration of the surgery (several hours)

Participants undergo elective on-pump coronary artery bypass grafting surgery during which Bispectral Index (BIS) and Patient State Index (PSI) are monitored simultaneously at predefined time points throughout normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass.

1 surgical procedure visit (in-person)

Postoperative Observation

Duration - Follow-up as per routine clinical care

Participants are observed postoperatively as part of routine care; data collection focuses on intraoperative monitoring outcomes.

Visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

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

Sakarya, Serdivan, Turkey (Türkiye)

Actively Recruiting

Loading map...

Research Team

A

AHMET R DOĞAN, M.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

The Effect of Amobarbital on Myocardial Protection and Progn...

Cardiopulmonary Bypass

Actively Recruiting

1 location

Extra-Cellular Hemoglobin and Organ Injury in Extended Cardi...

Cardiopulmonary Bypass

Actively Recruiting

1 location

Comparison of Femorofemoral Bypass and Left-Heart Bypass Tec...

Thoracoabdominal Aortic Aneurysm

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Changes in SedLine-derived processed electroencephalographic parameters during hypothermia in patients undergoing cardiac surgery with cardiopulmonary bypass.

Alessandro Belletti, Dong-Kyu Lee, Fumitaka Yanase...

https://pubmed.ncbi.nlm.nih.gov/37469479