Performance of Acceleromyography With and Without Preload

Phase 4

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Device: Hand Adapter (Organon, Oss, the Netherlands); Device: Placebo

• Registration Number: NCT00226018
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-26
• Study Completion: 2006-10
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-16
• Last Update Posted: 2008-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hand Adapter (Organon, Oss, the Netherlands)	Acceleromyography with Hand Adapter on dominant arm
2	Hand Adapter (Organon, Oss, the Netherlands)	Acceleromyography with Hand Adapter on non-dominant arm
3	Placebo	Acceleromyography without Hand Adapter on dominant arm
4	Placebo	Acceleromygraphy without Hand Adapter on non-dominant arm

Primary Outcome Measures

Name	Time	Method
The precision of acceleromyography with and without preload during recovery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dep. of anesthesia, HOC, Rigshospitalet; 🇩🇰 Copenhagen, Copenhagen Ø, Denmark