Performance of Acceleromyography With and Without Preload

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Device: Placebo; Device: Hand Adapter (Organon, Oss, the Netherlands)

Study type: Interventional

Funder types: Other

Identifiers

NCT00226018

AMG01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Acceleromyography with Hand Adapter on dominant arm

Treatment:

Device: Hand Adapter (Organon, Oss, the Netherlands)

2

Active Comparator group

Description:

Acceleromyography with Hand Adapter on non-dominant arm

Treatment:

Device: Hand Adapter (Organon, Oss, the Netherlands)

3

Placebo Comparator group

Description:

Acceleromyography without Hand Adapter on dominant arm

Treatment:

Device: Placebo

4

Placebo Comparator group

Description:

Acceleromygraphy without Hand Adapter on non-dominant arm

Treatment:

Device: Placebo