The Staircase Phenomenon Implications on Neuromuscular Block Monitoring

NCT ID: NCT03146767

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Blockade Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tetanic Group

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.

Group Type EXPERIMENTAL

Tetanus stabilization of baseline

Intervention Type 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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Fe

OTHER

Sponsor Role lead

Responsible Party

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Oscar Diaz-Cambronero

Anesthesiology Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario La Fe

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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MAZ0816

Identifier Type: -

Identifier Source: org_study_id

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