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Completed

NCT Number: NCT00472121

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

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Anaesthesia

Copenhagen, 2100, Denmark

Who can participate

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

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

Treatment and study plan

TOF-Watch SX (neuromuscular monitor)

Device

The variation between arms (dominant or non-dominant) when monitored with the same method on both arms

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 11, 2007
Registry last updated
Apr 18, 2008

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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