Performance of Acceleromyography With and Without Preload

Neuromuscular Blockade Clinical Trial

Official title:

Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226018
• Other study ID #: AMG01
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2005
• Last updated: April 16, 2008
• Start date: March 2005
• Est. completion date: October 2006

Study information

• Verified date: April 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• 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)
• Placebo
placebo

Locations

Country	Name	City	State
Denmark	Dep. of anesthesia, HOC, Rigshospitalet	Copenhagen	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The precision of acceleromyography with and without preload during recovery
Secondary	Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
Secondary	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":
Secondary	Bias og limits of agreement between control TOF
Secondary	Onset time
Secondary	Time to reappearance of T1, T2, T3 and T4
Secondary	Twitch height of T1 at reappearance of T1, T2, T3 and T4
Secondary	Time to T1=25%
Secondary	Interval 25-75%
Secondary	Time to TOF-ratio = 0.9 and 1.0
Secondary	Time to final T1
Secondary	Time to final TOF ratio