The Staircase Phenomenon and His Implications on Neuromuscular Block Monitoring During General Anesthesia
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
- 否
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
Oscar Diaz-Cambronero
Anesthesiology Consultant
Hospital Universitario La Fe
