The Precision and Arm-to-Arm Variation of Mechanomyography and Acceleromyography for Monitoring of Neuromuscular Block

Neuromuscular Blockade Clinical Trial

Official title:

The Precision and Arm-to-Arm Variation og Mechanomyography and Acceleromyography for Monitoring the Neuromuscular Block During Anesthesia, A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472121
• Other study ID #: MMG-MMG
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2007
• Last updated: April 17, 2008
• Start date: May 2007
• Est. completion date: October 2007

Study information

• Verified date: April 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Our hypothesis is that there is no significant difference in neither the precision nor the level of block in the contralateral arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I-III

• General anesthesia >1 hour

• Surgery in supine position w. possibility of monitoring the neuromuscular block at both arms (n. ulnaris stimulation/thumb response)

• 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 anaesthesia

• Body weight less or exceeding 20% of ideal body weight

• Pregnancy or breastfeeding

Study Design

N/A

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• TOF-Watch SX (neuromuscular monitor)
The variation between arms (dominant or non-dominant) when monitored with the same method on both arms

Locations

Country	Name	City	State
Denmark	Dep. of Anaesthesia	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time
Secondary	Bias and limits of agreement between control TOF, reappearance of T1, T2, T3, T4
Secondary	T1 height at reappearance of T1-T4
Secondary	Time to T1=25%
Secondary	Interval 25-75%
Secondary	Time to TOF 0.9 and 1.0 with and without normalization
Secondary	Time to stable T1 and stable TOF