NCT07508579 Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass
| NCT ID | NCT07508579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sakarya University |
| Condition | Cardiopulmonary Bypass |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-05-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
AYÇA TAŞ TUNA, Professor, M.D.
PRINCIPAL INVESTIGATOR
Sakarya University Faculty of Medicine
Frequently Asked Questions
Who can join the NCT07508579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cardiopulmonary Bypass. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07508579 currently recruiting?
Yes, NCT07508579 is actively recruiting participants. Contact the research team at a.ridvandogan@gmail.com for enrollment information.
Where is the NCT07508579 trial being conducted?
This trial is being conducted at Sakarya, Turkey (Türkiye).
Who is sponsoring the NCT07508579 clinical trial?
NCT07508579 is sponsored by Sakarya University. The principal investigator is AYÇA TAŞ TUNA, Professor, M.D. at Sakarya University Faculty of Medicine. The trial plans to enroll 60 participants.