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Completed

NCT Number: NCT00226018

Performance of Acceleromyography With and Without Preload

The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dep. of anesthesia, HOC, Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-III
  • General anesthesia > 1 hour
  • Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
  • 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 anesthesia
  • Body weight less or exceeding 20% of the ideal body weight
  • Pregnancy or breastfeeding

Treatment and study plan

Hand Adapter (Organon, Oss, the Netherlands)

Device

Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring)

PLACEBO

Device

placebo

Primary outcomes

  1. The precision of acceleromyography with and without preload during recovery

Secondary outcomes

  1. Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery

  2. All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":

  3. Bias og limits of agreement between control TOF

  4. Onset time

  5. Time to reappearance of T1, T2, T3 and T4

  6. Twitch height of T1 at reappearance of T1, T2, T3 and T4

  7. Time to T1=25%

  8. Interval 25-75%

  9. Time to TOF-ratio = 0.9 and 1.0

  10. Time to final T1

  11. Time to final TOF ratio

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

Important dates

Study start
2005
Study completion
2006
First posted
Sep 26, 2005
Registry last updated
Apr 17, 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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