The Staircase Phenomenon Implications on Neuromuscular Block Monitoring

NCT03146767 | Completed

• 1 other identifier: MAZ0816
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

Tetanic Group

EXPERIMENTAL

A Tetanic stimulation (Tetanus stabilization of baseline) is administered to the monitorized arm before calibrating the neuromuscular block monitor. Then Train-of-four (TOF) stimuli are administered every 20 seconds for 20 minutes.

Device: Tetanus stabilization of baseline

Control Group

NO INTERVENTION

Conventional monitor baseline stabilization: Train-of-four stimuli are administered every 20 seconds for 20 minutes

Interventions

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

Tetanic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitario La Fe

Valencia, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Consultant

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 10, 2017
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

ES (1)