The Relationship Between Burst Suppression Observed During Anesthesia Induction and the Bispectral Index Value During the Maintenance Phase of Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- TBIS<40
研究概览
简要总结
The purpose of this study is to understand whether certain brain activity patterns that can appear at the beginning of anesthesia are related to how deep anesthesia remains during the operation.
The main question of the study is:
Do patients who show a pattern called burst suppression during the start of anesthesia experience deeper anesthesia during surgery?
Patients who are scheduled for elective surgery under total intravenous anesthesia (TIVA) may take part in this study. During the operation, brain activity will be monitored using a sensor placed on the forehead (Bispectral Index, BIS monitor), which is already commonly used during anesthesia. Information such as BIS values and the doses of anesthesia medications given during the operation will be recorded.
Participation in this study will not change the type of anesthesia or the routine care that patients receive during surgery. The study only involves recording and analyzing information collected during standard anesthesia monitoring.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective surgery
- •Surgery planned to be performed under total intravenous anesthesia (TIVA)
排除标准
- •Presence of neurological disease
- •Chronic use of sedative medications or antiepileptic drugs
- •Severe hepatic or renal dysfunction
- •Intraoperative administration of ketamine or dexmedetomidine
研究组 & 干预措施
Burst Suppression Group
Patients who exhibited burst suppression during the anesthesia induction period, defined as a burst suppression ratio of ≥10% lasting for at least 1 minute
Non-Burst Suppression Group
Patients who did not exhibit burst suppression during the anesthesia induction period, defined as the absence of burst suppression with a burst suppression ratio ≥10% lasting for at least 1 minute
结局指标
主要结局
TBIS<40
时间窗: During intraoperative period
Total duration during the maintenance phase of anesthesia in which the BIS remains below 40, expressed as a proportion of total surgical time, compared between patients with and without burst suppression during induction
次要结局
- TBIS40-60(During intraoperative period)
- TBIS>60(During intraoperative period)
- TLOC(During induction of anesthesia)
- BIS-LOC(At the exact time of loss of consciousness (LOC))
- TROC(During emergence from anesthesia)
- BIS-ROC(At the moment of response to verbal commands during emergence from anesthesia)
- Propofol infusion rate during anesthesia(During the intraoperative period)
- Remifentanil infusion rate during anesthesia(During the intraoperative period)
研究者
Bülent Meriç Çam
Specialist Physician
Amasya University