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临床试验/NCT00714974
NCT00714974已完成不适用

A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

University of Utah0 个研究点目标入组 56 人开始时间: 2000年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
主要终点
Amount of sedation required.

研究概览

简要总结

This is a prospective, randomized, blinded study in which patients will be enrolled into either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents.

To collect pertinent data on critically ill patients while they are receiving NMBA's. In particular to correlate sedation/analgesic medication needs between a group whose medication use is determined by the values obtained by bispectral analysis to a group who will have medications delivered by the standard of care presently used in the intensive care unit in which they are being treated.

To document that patients who are monitored with bispectral analysis are able to achieve an appropriate level of consciousness in a shorter time and require less manipulation and amounts of sedative or analgesic medications than those who are not monitored.

详细描述

This is a prospective, randomized and blinded study being done in order to help evaluate the level of consciousness with bispectral analysis (BIS) in ICU patients who are pharmacologically paralyzed with NMBAs (neuromuscular blockade agents) and to assess such things as the amount of time required to achieve the appropriate level of sedation/analgesia. Data will be collected and evaluated via this FDA approved equipment. The intent of this project is to evaluate this technology in those who are requiring "anesthesia" like states (use of NMBAs) for prolonged periods in the critically ill patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Consented ICU patient, receiving neuromuscular blocking agents.

排除标准

  • Unable to be consented

结局指标

主要结局

Amount of sedation required.

时间窗: During period of neuromuscular blockade use in ICU

次要结局

  • Time requiring neuromuscular blockade and mechanical ventilation.(Time in ICU)

研究者

申办方类型
Other

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