The Staircase Phenomenon Implications on Neuromuscular Block Monitoring

Neuromuscular Blockade Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146767
• Other study ID #: MAZ0816
• Status: Completed
• Phase: N/A
• First received: April 25, 2017
• Last updated: May 5, 2017
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2017
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade Monitoring

Intervention

Device:
• Tetanus stabilization of baseline
Administering a Tetanic stimulus before baseline stabilization shortens the stabilization period of baseline of a neuromuscular block monitor. This acts on the baseline value

Locations

Country	Name	City	State
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Block Onset time difference (seconds)	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)	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	Difference in time until recovery of a TOF ratio (TOFr) of 0.9	Time until recovery of a TOF ratio of 0.9 (reversal of neuromuscular block as assessed by the monitor). During recovery phase stimuli regain height until all four stimuli of the Train-of-Four are present. Train-of-Four ratio is the ratio between the fourth and the first stimuli (T4/T1).	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).
Secondary	Difference in TOFr 0.9 Normalized	Time until recovery of a TOF ratio of 0.9 normalized to baseline TOR ratio after calibration. (e.g. if baseline TOF ratio is 1.1, normalized TOF ratio 0.9 is: 1.1 x 0.9 = 0.99)	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).
Secondary	Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25)	Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus during recovery phase. During recovery phase stimuli begin to recover and their height increases. This outcome is the time between the beginning of neuromuscular block until recovery of 25% of height of the first stimulus of the Train-of-Four.recovery phase. During recovery phase stimuli begin to recover and their height increases. This outcome is the time between the beginning of neuromuscular block until recovery of 25% of height of the first stimulus of the Train-of-Four (TOF)	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)
Secondary	Time between 25% and 75% of maximum twitch height recovery of T1 stimulus	Time between 25% and 75% height recovery of maximum twitch height in the recovery phase.	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).
Secondary	Difference between first stimulus of Train-of-Four ratio at baseline	Difference between T1 at baseline. Train-of-Four ratio is the administration of four consecutive stimuli to the monitored muscle. These stimuli are named T1,T2,T3,T4. This is the difference between tow arms oh T1 height 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
Secondary	Difference between T1 height after stabilization period of 20 minutes	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
Secondary	Difference between TOF ratio at baseline time	Difference between TOF ratio at baseline time	Single measurement of muscle response after calibration procedure at the beginning of data recording.
Secondary	Difference between TOF ratio after stabilization period time	Difference between TOF ratio after stabilization period time	Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation.
Secondary	Monitor Sensitivity difference between groups	Sensitivity parameter is set by monitor after calibration.	Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
Secondary	Monitor Amperage Intensity after calibration difference (milliAmperes, mA)	Monitor Amperage Intensity is set by the monitor after calibration	Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
Secondary	T1/TOFratio relationship difference	During recovery phase T1 over TOF ratio will be calculated and the difference between two groups will be assessed.	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