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临床试验/NCT02687568
NCT02687568Unknown不适用

Values of Enhanced Monitoring by EEG Recording ( Narcotrend ) as an Adjunct to Standard Monitoring for Sedation in Colonoscopy

Ruhr University of Bochum1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
mean recovery time after propofol sedation for colonoscopy using the EEG recording EEG monitoring at stage D0 to D2

研究概览

简要总结

Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally recommended under sedation and also carried out in practice here.

The vital signs monitoring to avoid complications is dictated by current national guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In patients with severe heart disease an ECG recording should be used additionally. Moreover, the guidelines require that the sedation is clinically monitored continuously to avoid an unwanted anesthetic stage. Such evaluation, however, is often difficult under clinical conditions and even counterproductive, since a constant response and tactile stimulation of the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex intervention. However, clinical most relevant aspect is the avoidance of unrecognized transition of patients from the stage of deep sedation in an anesthetic stage.

Current recommendations do not take into account new study results from a gender perspective, which showed that women and men need a different wake-up time using the EEG derivation means by using the Narcotrend after total intravenous anesthesia, which may be due to different total doses of sedatives needed. However, the research group has been demonstrated in a previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time by a lower dose of the administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde cholangiopancreatography-(ERCP).

In the presented study the investigators evaluate the extent of gender differences in the wake-up time after sedation with propofol during colonoscopy when using EEG monitoring.

详细描述

Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally recommended under sedation and also carried out in practice here.

In interventional and longer lasting interventions (for example colonoscopy, endoscopic ultrasonography, ERCP) as opposed to purely diagnostic examinations is often deep sedation.Use of propofol in terms of sedation efficacy and the wake-up time or quality is superior to the use of benzodiazepines (plus opiates) , while patient safety is the same.

The vital signs monitoring to avoid complications is dictated by current national guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In patients with severe heart disease an ECG recording should be used additionally. Moreover, the guidelines require that the sedation is clinically monitored continuously to avoid an unwanted anesthetic stage. Such evaluation, however, is often difficult under clinical conditions and even counterproductive, since a constant response and tactile stimulation of the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex intervention. However, clinical most relevant aspect is the avoidance of unrecognized transition of patients from the stage of deep sedation in an anesthetic stage.

Current recommendations do not take into account new study results from a gender perspective, which showed that women and men need a different wake-up time using the EEG derivation means by using teh Narcotrend after total intravenous anesthesia, which may be due to different total doses of sedatives needed. However, the research group has beendemonstrated in a previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time by a lower dose of the administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde cholangiopancreatography-(ERCP).

In the presented study investigators evaluate the extent of gender differences in the wake-up time after sedation with propofol during colonoscopy when using EEG monitoring.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age > 18
  • Clinical indication for colonoscopy

排除标准

  • Lack of consent of the patient
  • ASA (American Society of Anesthesiologists) class V
  • Known Pregnancy
  • Emergency investigations
  • Pre-existent hypotension (RRsys <90mmHg), bradycardia (HR <50 / min), hypoxia (SaO2 <90%)

结局指标

主要结局

mean recovery time after propofol sedation for colonoscopy using the EEG recording EEG monitoring at stage D0 to D2

时间窗: Immediately after the procedure

次要结局

未报告次要终点

研究者

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

Andrea Riphaus

PD Dr. Andrea Riphaus

Ruhr University of Bochum

研究点 (1)

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