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临床试验/NCT03114774
NCT03114774Unknown不适用

Evaluation of Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography Received Sedoanalgesia

Istanbul Medeniyet University0 个研究点目标入组 60 人开始时间: 2017年4月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Total dosage of propofol

研究概览

简要总结

The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100, wide awake) BIS monitoring allows noninvasive, objective measurement of level of consciousness of a sedated patient. A limited number of studies have used measurements of BIS monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make sedation easy for ERCP procedures. However, the studies evaluating use of BIS for gastrointestinal endoscopy show inconsistent results.

The objective of this study is to evaluate effects of sedation on the dosage of propofol by monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk for respiratory depression using minimal doses of propofol in order to achieve the desired level of sedation with BIS 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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 20-75 years old

排除标准

  • Emergency Operation
  • Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
  • Patients that are allergic to drugs considered to use

结局指标

主要结局

Total dosage of propofol

时间窗: 1-3 hours

initial dose 1 mg.kg-1 of propofol, maintenance dose: infusion of 4 mg/kg/h . In case of insufficient sedation, additional dose of 0.1 mg/kg propofol (IV) by monitoring with BIS values 65-75 during procedure

The heart rate (HR)(n/dk)

时间窗: 1-3 hours

During procedure

peripheral oxygen saturation (%)

时间窗: 1-3 hours

During procedure

mean systolic-diastolic blood pressure(mmHg)

时间窗: 1-3 hours

during procedure

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferda Yilmaz Inal

Assistant Professor

Istanbul Medeniyet University

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