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临床试验/NCT07508579
NCT07508579进行中(未招募)不适用

Effect of Hypothermia on the Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) During Cardiopulmonary Bypass

Sakarya University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2

研究概览

简要总结

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

详细描述

Hypothermia during cardiopulmonary bypass (CPB) is known to influence cerebral metabolism and electroencephalographic activity. Processed electroencephalography-derived indices such as the Bispectral Index (BIS) and Patient State Index (PSI) are commonly used to monitor anesthetic depth; however, these indices are generated using different proprietary algorithms. While previous studies have demonstrated moderate to high correlation between BIS and PSI under normothermic conditions, it remains unclear whether this relationship is preserved during hypothermic CPB.

This prospective observational study aims to evaluate the effect of hypothermia on the relationship between BIS and PSI in adult patients undergoing elective on-pump coronary artery bypass grafting. Both indices will be monitored simultaneously throughout the intraoperative period using standard sensor placement.

Data will be collected at predefined time points representing normothermic, hypothermic, and rewarming phases of CPB. The primary analysis will focus on comparing the correlation between BIS and PSI at a normothermic reference point (36°C) and a hypothermic reference point (32°C).

To minimize confounding effects, anesthetic management and physiological parameters will be maintained within routine clinical target ranges, and relevant variables will be recorded throughout the procedure. Secondary analyses will explore temperature-dependent changes in each index and agreement between clinically relevant depth-of-anesthesia categories.

This study is designed to clarify whether hypothermia alters the relationship between commonly used processed EEG indices, which may have implications for intraoperative neuromonitoring and anesthetic management during cardiac surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery
  • Planned use of general anesthesia
  • Written informed consent

排除标准

  • Preexisting neurological disease
  • Use of medications affecting Electroencephalography (e.g., antiepileptics)
  • Severe hepatic dysfunction
  • Emergency surgery
  • Inadequate signal quality for anesthesia depth monitoring

研究组 & 干预措施

Elective On-Pump CABG Patients Undergoing CPB

Adult patients undergoing elective on-pump coronary artery bypass grafting with cardiopulmonary bypass will be included. All participants will receive standard general anesthesia and intraoperative management according to institutional protocols. Bispectral Index (BIS) and Patient State Index (PSI) will be monitored simultaneously throughout surgery. Data will be collected at predefined time points across normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass to evaluate the relationship between these indices under varying temperature conditions.

干预措施: Simultaneous BIS and PSI Monitoring (Other)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Taş Tuna

Prof.Dr.

Sakarya University

研究点 (2)

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