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

Hospital Universitario La Fe1 site in 1 country50 target enrollmentFebruary 2013

ConditionsNeuromuscular Blockade Monitoring

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuromuscular Blockade Monitoring
Sponsor: Hospital Universitario La Fe
Enrollment: 50
Locations: 1
Primary Endpoint: Difference in Block Onset time difference (seconds)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

March 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitario La Fe

Responsible Party

Principal Investigator

Oscar Diaz-Cambronero

Anesthesiology Consultant

Hospital Universitario La Fe

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

Outcomes

Primary Outcomes

Difference in Block Onset time difference (seconds)

Time Frame: 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)

Secondary Outcomes

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)