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Clinical Trials in Turkey / NCT07042906
Active, not recruiting Observational

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

NCT07042906 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2024-01-18
Last updated
2025-06-29

Condition(s) studied

BIS-EEGPSIOpen Heart SurgeryAnesthesia Depth Monitoring

Investigational drug(s) / intervention(s)

anesthesia depth monitorizing, awareness

anesthesia depth monitorizing, awareness: Investigation of BIS and PSI Monitoring Methods for Anesthetic Depth and the Factors Affecting These Methods in Open-Heart Surgery

Study 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."

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kocaeli University Köseköy Kocaeli

More Kocaeli University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07042906 on ClinicalTrials.gov ↗ ← All trials in Turkey