Incidence of Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change from baseline of the Mini-Mental test examination score 15 min post anesthesia
研究概览
简要总结
This study is designed to test the hypothesis that closed loop system reduces post operative cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane, total intravenous anesthesia manually guided by bispectral index in urologic surgical patients.
The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs younger surgical patients.
详细描述
Postoperative cognitive dysfunction (POCD) is a transient cognitive impairment manifested by compromised memory and concentration with altered performance on intellectual tasks that can affect patients of any age but it is more frequent in advanced age people after anesthesia.
Recently clinical research has demonstrated the efficacy of computer- controlled endovenous drug delivery system guided by bispectral index score (BIS) of the electroencephalogram as the control variable. The BIS closed loop (CL) titration of propofol and remifentanyl target control infusion provides clinically adequate anesthesia with stability of cardiovascular parameters and favorable patients outcomes, including decreasing drug consumption and shortened postoperative recovery times when compared with manual control infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 18 years
- •Patients undergoing elective urologic surgery under general anesthesia expected 2 hours
- •American Society of Anesthesiology physical status II- III
排除标准
- •Patients with body mass index greater than 30,
- •Patients with clinically significant cardiopulmonary, hepatic, renal disorders, neurological, psychiatric or metabolic disease
- •Patients unable to read and write and with impaired hearing
研究组 & 干预措施
Auto Total endovenous anesthesia
The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158
干预措施: auto total endovenous anesthesia (Device)
Manual Desflurane anesthesia
The anesthesia will be maintained with desflurane to target the BIS of 50.
干预措施: Manual Desflurane anesthesia (Device)
Manual sevoflurane anesthesia
The anesthesia will be maintained with sevoflurane to target the BIS of 50.
干预措施: Manual Sevoflurane anesthesia (Device)
Manual total endovenous anestesia
In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50
干预措施: Manual total endovenous anesthesia (Device)
结局指标
主要结局
Change from baseline of the Mini-Mental test examination score 15 min post anesthesia
时间窗: 15 minutes before anesthetic procedures and 15 min after the end of general anesthesia
The Mini-Mental State Examination (MMSE) test will be given 15 min before the anesthetic procedure and 15 min after the end of anesthesia.
次要结局
未报告次要终点
研究者
Cotoia Antonella
Prof.
University of Foggia