SedLine EEG-Guided Depth of Anesthesia: Effect of Anesthetic Dosage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Total Average Anesthetic
研究概览
简要总结
The purpose of our study is to determine if monitoring sedation (how asleep patients are under general anesthesia) using a device called a Sedline Monitor affects the amount of anesthesia patients receive.
详细描述
The main objective of this study is to determine if monitoring sedation using the FDA approved device, Sedline Monitor, affects the amount of anesthesia patients 65 or older receive during surgery. Reducing the anesthetic dose could result in less exposure of anesthetic medications to a high-risk patient population as well as a potential reduction in cost. Subjects will be randomized into either a control group or study group and have the Sedline Monitor placed on their head before the start of their already scheduled surgery. During the surgery, subjects in the control group will receive standard anesthesia care and the study group will receive anesthetic drug doses guided by Sedline Monitor processed EEG characteristics. When the surgery is complete, the Sedline Monitor will be removed and subject participation will be finished. The study team will also collect information about subjects from their medical records and use it for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing a scheduled surgery (laparotomy, hepatobiliary surgery, gynecologic surgery, and/or urologic surgery procedures) at Indiana University Health University Hospital that is expected to have at least a 3 day post-operative hospital stay.
- •ASA class 1, 2, 3, or
- •Age 65 years or older.
- •Male or Female
- •Surgical procedure requiring general anesthesia.
排除标准
- •Any previous diagnosis of dementia or other cognitive impairment.
- •Any patient undergoing emergency surgery.
- •Any patient undergoing surgery who is currently an inpatient.
- •Patient refusal to participate in study.
- •Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp).
- •Any physical, mental, or medical conditions which, in the opinion of the investigators, may confound the ability to assess the patient for delirium in the post-operative period.
结局指标
主要结局
Total Average Anesthetic
时间窗: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).
次要结局
- Total Hypnotic Agents (Fentanyl)(5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given)
- Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)(5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given)
- Time Period of Hypotension(5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given)
- Occurrence of EEG Isoelctricity(5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours)
- Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)(5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given)
- Total Dosage of Vasopressor (Vasopressin)(5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given)
- Total Dosage of Vasopressor (Ephedrine)(5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given)
研究者
Timothy Webb
Assistant Professor of Clinical Anesthesia
Indiana University