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临床试验/NCT03146767
NCT03146767已完成不适用

The Staircase Phenomenon and His Implications on Neuromuscular Block Monitoring During General Anesthesia

Hospital Universitario La Fe1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013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
50
试验地点
1
主要终点
Difference in Block Onset time difference (seconds)

研究概览

简要总结

The staircase phenomenon could have repercussions on the onset and recovery time following administration of a neuromuscular blocking agent. The investigators aim to assess the magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular blockade with a randomized controlled double blind trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

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

  • ASA (American Society of Anesthesiology surgical risk scale) grade I - II
  • Surgery not involving airway performed under general anaesthesia with neuromuscular blocker

排除标准

  • Pregnancy
  • BMI (Body Mass Idex) > 35 Kg/m2
  • Anticipated difficult airway
  • Chronic kidney or hepatic failure
  • Neuromuscular disease
  • Medication that has known interactions with neuromuscular blockers
  • Hemodynamic failure
  • Anticipated large blood loss

结局指标

主要结局

Difference in Block Onset time difference (seconds)

时间窗: rom 0 seconds up to 240 seconds after neuromuscular block administration at the beginning of surgery. Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).

Onset time is the time between Train of Four (TOF) at the moment of injection of neuromuscular blocking drug and the minimum value reached (onset of neuromuscular block)

次要结局

  • Difference in time until recovery of a TOF ratio (TOFr) of 0.9(From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).)
  • Difference in TOFr 0.9 Normalized(From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).)
  • Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25)(From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery.(up to 4 hours))
  • Time between 25% and 75% of maximum twitch height recovery of T1 stimulus(From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).)
  • Difference between first stimulus of Train-of-Four ratio at baseline(Single measurement of muscle response after calibration procedure at the beginning of data recording after randomization. It is not a time-to-event variable)
  • Difference between TOF ratio after stabilization period time(Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation.)
  • Difference between T1 height after stabilization period of 20 minutes(Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. It is not a time-to-event variable)
  • Difference between TOF ratio at baseline time(Single measurement of muscle response after calibration procedure at the beginning of data recording.)
  • Monitor Sensitivity difference between groups(Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization))
  • Monitor Amperage Intensity after calibration difference (milliAmperes, mA)(Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization))
  • T1/TOFratio relationship difference(Ratio of specified values recorded by the monitor at the beginning of surgery until onset of neuromuscular block (up to 180 seconds) and during spontaneous recovery up to 4 hours until end of anesthesia)

研究者

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

Oscar Diaz-Cambronero

Anesthesiology Consultant

Hospital Universitario La Fe

研究点 (1)

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