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Completed

NCT Number: NCT03146767

The Staircase Phenomenon Implications on Neuromuscular Block Monitoring

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.

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Key information

Conditions

Neuromuscular Blockade Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Fe

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetanus stabilization of baseline

Device

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

Primary outcomes

  1. 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

  1. Difference in time until recovery of a TOF ratio (TOFr) of 0.9

    Time frame: 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).

    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).

  2. Difference in TOFr 0.9 Normalized

    Time frame: 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 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)

  3. Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25)

    Time frame: 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 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)

  4. Time between 25% and 75% of maximum twitch height recovery of T1 stimulus

    Time frame: 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).

    Time between 25% and 75% height recovery of maximum twitch height in the recovery phase.

  5. Difference between first stimulus of Train-of-Four ratio at baseline

    Time frame: 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 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

  6. Difference between T1 height after stabilization period of 20 minutes

    Time frame: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. It is not a time-to-event variable

    Difference between T1 height after stabilization period of 20 minutes

  7. Difference between TOF ratio at baseline time

    Time frame: Single measurement of muscle response after calibration procedure at the beginning of data recording.

    Difference between TOF ratio at baseline time

  8. Difference between TOF ratio after stabilization period time

    Time frame: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation.

    Difference between TOF ratio after stabilization period time

  9. Monitor Sensitivity difference between groups

    Time frame: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)

    Sensitivity parameter is set by monitor after calibration.

  10. Monitor Amperage Intensity after calibration difference (milliAmperes, mA)

    Time frame: 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 is set by the monitor after calibration

  11. T1/TOFratio relationship difference

    Time frame: 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

    During recovery phase T1 over TOF ratio will be calculated and the difference between two groups will be assessed.

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 10, 2017
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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