Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.
2019年6月27日 更新者：Claudia Spies
Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study. A Single- Center Prospective Randomized Controlled Pilot Study.
This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to optimized outcome compared to manually controlled clinical anesthesia and computerized Electroencephalogram (EEG).
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berlin、德国、13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Male/female patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia at Charité - Universitaetsmedizin Berlin, Campus Mitte and Campus Virchow-Klinikum
描述
Inclusion Criteria:
- Offered patient information and written informed consent
- Male/female patients with intended ratio of 1:1
- patients aged greater than or equal to 60 years
- scheduled duration of surgery longer than or equal to 60 minutes
- elective surgery (general/abdominal surgery, traumatological/orthopedic surgery, gynecology, urology) in general anesthesia
Exclusion Criteria:
- Persons without the capacity to consent
- Unability of German language use
- Lacking willingness to save and hand out data within the study
- Participation in another study according to the German Medicinal Products Act within 30 days before participation in the Smart-Outcome study
- Accommodation in an institution due to an official or judicial order
- (Unclear) history of alcohol or substances disabuse
- Member of staff of the Charité
- Neurological or psychiatric disease
- American Society of Anaesthesiologists (ASA) classification greater than or equal to class IV
- Moribund patients
Due to the underlying PKPD models of the SmartPilot® system, patient with the following characteristics cannot be anesthetized using SmartPilot®:
- Height < 150 or > 200 cm, respectively
- Weight < 40 or > 140 kg, respectively
- Body Mass Index > 30
- Age < 18 or > 90 years of age, respectively
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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SmartPilot® system
50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia using the SmartPilot® system
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Standard arm
50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia according to the standard operating procedures of the department, i.e. manually controlled clinical anesthesia and EEG-derived parameters of anesthetic depth
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative delirium
大体时间：In the 8-day postoperative sample period
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Nursing Delirium Csreening Scale (Nu-DESC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), International Classification of Diseases (ICD-10)
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In the 8-day postoperative sample period
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Postoperative cognitive deficit
大体时间：In the 8-day postoperative sample period
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Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test
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In the 8-day postoperative sample period
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Wake-up time
大体时间：In the 8-day postoperative sample period
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In the 8-day postoperative sample period
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Duration of treatment in the recovery room
大体时间：In the 8-day postoperative sample period
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In the 8-day postoperative sample period
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Correlation of EEG-based depth of anesthesia (BIS®) with PK/PD-based Noxious Stimulus Response Index (NSRI) of the SmartPilot® system.
大体时间：In the 8-day postoperative sample period
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In the 8-day postoperative sample period
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Correlation of Bispectral index (BIS®)- and NSRI readings with Near infrared spectroscopy (NIRS) - readings as parameters of regional cerebral oxygen saturation.
大体时间：In the 8-day postoperative sample period
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In the 8-day postoperative sample period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Spies Claudia, MD, Prof.、Charite University, Berlin, Germany
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年11月12日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2017年7月14日
研究注册日期
首次提交
2012年9月25日
首先提交符合 QC 标准的
2012年9月25日
首次发布 (估计)
2012年9月27日
研究记录更新
最后更新发布 (实际的)
2019年6月28日
上次提交的符合 QC 标准的更新
2019年6月27日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.