Active — Not RecruitingNot Applicable

Comparison of the Factors Affecting PSI and BIS Values in Monitoring Anesthetic Depth During Open-Heart Surgery

Turkey (Türkiye)46 participantsStarted 2024-01-18

Plain-language summary

Measurement of anesthetic depth has long been a subject of investigation, aiming to titrate anesthetic agents appropriately and to prevent intraoperative awareness and consciousness. Many patients undergoing surgery experience fear and anxiety regarding the possibility of remaining conscious, perceiving pain, and being unable to move during anesthesia. Intraoperative awareness-defined as consciousness during anesthesia with explicit recall afterward-is a distressing condition that can lead to post-traumatic stress disorder. However, aiming for excessively deep anesthesia to avoid the possibility of awareness during surgery is not recommended, as it may result in hemodynamic instability due to the effects of anesthetic agents and may impair postoperative cognitive functions, particularly in the elderly population. Common methods used in monitoring anesthetic depth include observing sweating, lacrimation, pupillary dilation, heart rate variability, and blood pressure. However, some of these are subjective and may not always be reliable indicators. Electroencephalogram (EEG)-based monitors such as the Bispectral Index (BIS) and the Patient State Index (PSI) offer more reliable and objective means of monitoring anesthetic depth. These monitors provide numerical values between 0 (indicating unconsciousness) and 100 (indicating full alertness) based on proprietary algorithms, offering valuable insight into the patient's anesthetic state. "Our aim is to examine BIS and PSI values and to investigate the factors that influence these parameters."

Who can participate

Age range

18 Years – 65 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: * "Patients aged 18 to 65 years, * Classified as ASA (American Society of Anesthesiologists) physical status II-III, * scheduled for elective open-heart surgery via median sternotomy Exclusion Criteria: * "Patients with an ejection fraction below 35%, * Those with pre-existing central nervous system disorders (e.g., history of epileptic seizures or intracranial space-occupying lesions), * A history of prior open cranial surgery, * Known allergies to anesthetic agents, alcohol or substance abuse, * Any other conditions deemed to negatively affect the BIS profile (e.g., patients with preoperative intra-aortic balloon pump insertion, those undergoing surgery under inotropic support, or receiving preoperative sedative infusions), * As well as patients scheduled to undergo antegrade or retrograde cerebral perfusion or total circulatory arrest

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

The primary objective of this study is to measure the correlation between BIS and PSI values, which are parameters used to monitor the depth of anesthesia during open-heart surgery.

Timeframe: Data will be collected over a 12-month period and subjected to statistical analysis.

Trial details

NCT IDNCT07042906

SponsorKocaeli University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-18

View on ClinicalTrials.gov More BIS-EEG trials