Clinical trial NCT03146767: The Staircase Phenomenon Implications on Neuromuscular Block Monitoring
Official title: The Staircase Phenomenon and His Implications on Neuromuscular Block Monitoring During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade Monitoring
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in Block Onset time difference (seconds)
timeFrame: 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).
Secondary outcomes:
measure: Difference in time until recovery of a TOF ratio (TOFr) of 0.9
timeFrame: 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).
measure: Difference in TOFr 0.9 Normalized
timeFrame: 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).
measure: Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25)
timeFrame: 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)
measure: Time between 25% and 75% of maximum twitch height recovery of T1 stimulus
timeFrame: 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).
measure: Difference between first stimulus of Train-of-Four ratio at baseline
timeFrame: Single measurement of muscle response after calibration procedure at the beginning of data recording after randomization. It is not a time-to-event variable
measure: Difference between T1 height after stabilization period of 20 minutes
timeFrame: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. It is not a time-to-event variable
measure: Difference between TOF ratio at baseline time
timeFrame: Single measurement of muscle response after calibration procedure at the beginning of data recording.
measure: Difference between TOF ratio after stabilization period time
timeFrame: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation.
measure: Monitor Sensitivity difference between groups
timeFrame: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
measure: Monitor Amperage Intensity after calibration difference (milliAmperes, mA)
timeFrame: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
measure: T1/TOFratio relationship difference
timeFrame: 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
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
References: