Performance of Acceleromyography With and Without Preload

Study Overview
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Brief Summary
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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.

Official Title
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Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Device: Hand Adapter (Organon, Oss, the Netherlands)
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Acceleromyography with Hand Adapter on dominant arm | Device: Hand Adapter (Organon, Oss, the Netherlands)<br>* 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)<br>|
| Active Comparator: 2<br>Acceleromyography with Hand Adapter on non-dominant arm | Device: Hand Adapter (Organon, Oss, the Netherlands)<br>* 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)<br>|
| Placebo Comparator: 3<br>Acceleromyography without Hand Adapter on dominant arm | Device: Placebo<br>* placebo<br>|
| Placebo Comparator: 4<br>Acceleromygraphy without Hand Adapter on non-dominant arm | Device: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The precision of acceleromyography with and without preload during recovery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |