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临床试验/NCT03804346
NCT03804346已完成不适用

Observational Study to Detect Postoperative Residual Curarization in Infantile Patients

University of Regensburg1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Residual paralysis

研究概览

简要总结

The primary object of this study is, to investigate the current procedure of neuromuscular monitoring at a tertiary academic university medical center.

详细描述

Residual neuromuscular block is known to be a significant but frequently overlooked complication after the use of neuromuscular blocking agents. Aim of this prospective, observational study is to detect the incidence and severity of residual paralysis at a tertiary academic german university medical center.

Methods:

All infantile patients recieving neuromuscular blocking agents are included over a 12 week observational period. At the end of the operation procedure, directly prior to tracheal extubation a train-of-four ratio was assessed quantitatively by an independet observer using the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the operating theatre, during the way to the postoperative care unit (PACU) and during the stay in the PACU:

  • incidence of residual paralysis
  • incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway obstruction,

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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • General aneasthesia with muscle relaxation
  • Children between 1 Month to 18 Years
  • Endotracheal Intubation due to surgical or diagnostical procedures

排除标准

  • older than 18 years
  • local aneasthesia
  • regional aneasthesia
  • larynx mask
  • patient comes from ICU
  • children who are not planned to be extubated

结局指标

主要结局

Residual paralysis

时间窗: Directly prior to extubation

Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.

次要结局

  • Airway obstruction(1, 10, 30, 60 minutes after extubation)
  • Oxygen desaturation(1, 10, 30, 60 minutes after extubation)
  • Bronchospasm, laryngospasm(1, 10, 30, 60 minutes after extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Unterbuchner

Principal Investigator, Dr. med. Christoph Unterbuchner, Staff Anaesthesiologist

University of Regensburg

研究点 (1)

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