- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226018
Performance of Acceleromyography With and Without Preload
April 16, 2008 updated by: Rigshospitalet, Denmark
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen Ø
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Copenhagen, Copenhagen Ø, Denmark, 2100
- Dep. of anesthesia, HOC, Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Acceleromyography with Hand Adapter on dominant arm
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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
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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
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placebo
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Placebo Comparator: 4
Acceleromygraphy without Hand Adapter on non-dominant arm
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placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The precision of acceleromyography with and without preload during recovery
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Secondary Outcome Measures
Outcome Measure |
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Time to T1=25%
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Interval 25-75%
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Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
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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":
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Bias og limits of agreement between control TOF
|
Onset time
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Time to reappearance of T1, T2, T3 and T4
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Twitch height of T1 at reappearance of T1, T2, T3 and T4
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Time to TOF-ratio = 0.9 and 1.0
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Time to final T1
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Time to final TOF ratio
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
October 1, 2006
Study Registration Dates
First Submitted
September 22, 2005
First Submitted That Met QC Criteria
September 22, 2005
First Posted (Estimate)
September 26, 2005
Study Record Updates
Last Update Posted (Estimate)
April 17, 2008
Last Update Submitted That Met QC Criteria
April 16, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- AMG01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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