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

NCT ID: NCT07042906

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-07-18

Brief 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."

Conditions

BIS-EEG; PSI; Open Heart Surgery; Anesthesia Depth Monitoring

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

anesthesia depth monitorizing, awareness

Investigation of BIS and PSI Monitoring Methods for Anesthetic Depth and the Factors Affecting These Methods in Open-Heart Surgery

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Mahsum Mazlum Mentes

residency doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University

Köseköy, Kocaeli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GOKAEK-2023/06.13

Identifier Type: -

Identifier Source: org_study_id