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Performance of Acceleromyography With and Without Preload

NCT ID: NCT00226018

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-10-31

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.

Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Acceleromyography with Hand Adapter on dominant arm

Group Type ACTIVE_COMPARATOR

Hand Adapter (Organon, Oss, the Netherlands)

Intervention Type DEVICE

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)

2

Acceleromyography with Hand Adapter on non-dominant arm

Group Type ACTIVE_COMPARATOR

Hand Adapter (Organon, Oss, the Netherlands)

Intervention Type DEVICE

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)

3

Acceleromyography without Hand Adapter on dominant arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

placebo

4

Acceleromygraphy without Hand Adapter on non-dominant arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

placebo

Interventions

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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)

Intervention Type DEVICE

Placebo

placebo

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Casper C Kjaer, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Dep. of anesthesia, HOC, Rigshospitalet

Copenhagen, Copenhagen Ø, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AMG01

Identifier Type: -

Identifier Source: org_study_id