The Precision and Arm-to-Arm Variation of Mechanomyography and Acceleromyography for Monitoring of Neuromuscular Block

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00472121
First received: May 10, 2007
Last updated: April 17, 2008
Last verified: April 2008
  Purpose

The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Our hypothesis is that there is no significant difference in neither the precision nor the level of block in the contralateral arms.


Condition Intervention Phase
Neuromuscular Blockade
Device: TOF-Watch SX (neuromuscular monitor)
Phase 4

Study Type: Observational
Official Title: The Precision and Arm-to-Arm Variation og Mechanomyography and Acceleromyography for Monitoring the Neuromuscular Block During Anesthesia, A Randomized Controlled Study

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time

Secondary Outcome Measures:
  • Bias and limits of agreement between control TOF, reappearance of T1, T2, T3, T4
  • T1 height at reappearance of T1-T4
  • Time to T1=25%
  • Interval 25-75%
  • Time to TOF 0.9 and 1.0 with and without normalization
  • Time to stable T1 and stable TOF

Study Start Date: May 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1: AMG Device: TOF-Watch SX (neuromuscular monitor)
The variation between arms (dominant or non-dominant) when monitored with the same method on both arms
2: MMG Device: TOF-Watch SX (neuromuscular monitor)
The variation between arms (dominant or non-dominant) when monitored with the same method on both arms

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • ASA I-III
  • General anesthesia >1 hour
  • Surgery in supine position w. possibility of monitoring the neuromuscular block at both arms (n. ulnaris stimulation/thumb response)
  • Written informed content

Exclusion Criteria:

  • Neuromuscular disorders, hepatic and renal dysfunction
  • Medication expected to interfere with the neuromuscular blocking agent
  • Allergy to any medication used during anaesthesia
  • Body weight less or exceeding 20% of ideal body weight
  • Pregnancy or breastfeeding
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00472121

Locations
Denmark
Dep. of Anaesthesia
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Casper C Kjær, MD Dep. of anaesthesia 4231, Rigshospitalet
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00472121     History of Changes
Other Study ID Numbers: MMG-MMG
Study First Received: May 10, 2007
Last Updated: April 17, 2008
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on September 16, 2014