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NCT07042906
Comparison of the Factors Affecting PSI and BIS Values in Monitoring Anesthetic Depth During Open-Heart Surgery
trial testing anesthesia depth monitorizing, awareness in BIS-EEG in 46 participants. Participants enrolled and being followed up; not accepting new ones.
18 January 2025
Quick facts
| Lead sponsor | Kocaeli University |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 46 |
| Start date | 18 January 2024 |
| Primary completion | 18 January 2025 |
| Estimated completion | 18 July 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- anesthesia depth monitorizing, awareness
Conditions studied
- BIS-EEG — all drugs for BIS-EEG →
- PSI — all drugs for PSI →
- Open Heart Surgery — all drugs for Open Heart Surgery →
- Anesthesia Depth Monitoring — all drugs for Anesthesia Depth Monitoring →
Sponsor
Kocaeli University
Who can join
Adults 18 to 65, any sex, with BIS-EEG or PSI. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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."
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07042906 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kocaeli University
- Last refreshed: 29 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07042906.
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