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

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ClinicalTrials.gov Identifier: NCT00472121
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : April 18, 2008
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment
Neuromuscular Blockade Device: TOF-Watch SX (neuromuscular monitor)

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
Study Start Date : May 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Group/Cohort Intervention/treatment
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



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

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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