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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
  Purpose

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.


Condition Intervention Phase
Neuromuscular Blockade
 Device: Hand Adapter (Organon, Oss, the Netherlands)
Device: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The precision of acceleromyography with and without preload during recovery

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: March 2005
Estimated Study Completion Date: October 2006
Arms Assigned Interventions
Active Comparator: 1
Acceleromyography with Hand Adapter on dominant arm
 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)
Active Comparator: 2
Acceleromyography with Hand Adapter on non-dominant arm
 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)
Placebo Comparator: 3
Acceleromyography without Hand Adapter on dominant arm
 Device: Placebo
placebo
Placebo Comparator: 4
Acceleromygraphy without Hand Adapter on non-dominant arm
 Device: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226018

Locations
Denmark
Dep. of anesthesia, HOC, Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Casper C Kjaer, MD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226018     History of Changes
Other Study ID Numbers: AMG01
Study First Received: September 22, 2005
Last Updated: April 16, 2008
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on May 21, 2013