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Performance of Acceleromyography With and Without Preload

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00226018
First received: September 22, 2005
Last updated: April 16, 2008
Last verified: April 2008
History of Changes

September 22, 2005
April 16, 2008
March 2005
Not Provided
The precision of acceleromyography with and without preload during recovery
Same as current
Complete list of historical versions of study NCT00226018 on ClinicalTrials.gov Archive Site
  • Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
  • 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":
  • Bias og limits of agreement between control TOF
  • Onset time
  • Time to reappearance of T1, T2, T3 and T4
  • Twitch height of T1 at reappearance of T1, T2, T3 and T4
  • Time to T1=25%
  • Interval 25-75%
  • Time to TOF-ratio = 0.9 and 1.0
  • Time to final T1
  • Time to final TOF ratio
Same as current
Not Provided
Not Provided
 
Performance of Acceleromyography With and Without Preload
Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuromuscular Blockade
  • Device: Hand Adapter (Organon, Oss, the Netherlands)
    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)
  • Device: Placebo
    placebo
  • Active Comparator: 1
    Acceleromyography with Hand Adapter on dominant arm
    Intervention: Device: Hand Adapter (Organon, Oss, the Netherlands)
  • Active Comparator: 2
    Acceleromyography with Hand Adapter on non-dominant arm
    Intervention: Device: Hand Adapter (Organon, Oss, the Netherlands)
  • Placebo Comparator: 3
    Acceleromyography without Hand Adapter on dominant arm
    Intervention: Device: Placebo
  • Placebo Comparator: 4
    Acceleromygraphy without Hand Adapter on non-dominant arm
    Intervention: Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2006
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00226018
AMG01
No
Not Provided
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Casper C Kjaer, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP