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

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00472121

Purpose

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.

Condition	Intervention	Phase
Neuromuscular Blockade	Device: TOF-Watch SX (neuromuscular monitor)	Phase IV

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time

Secondary Outcome Measures:

Bias and limits of agreement between control TOF, reappearance of T1, T2, T3, T4
T1 height at reappearance of T1-T4
Time to T1=25%
Interval 25-75%
Time to TOF 0.9 and 1.0 with and without normalization
Time to stable T1 and stable TOF

Study Start Date:	May 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1: AMG	Device: TOF-Watch SX (neuromuscular monitor) The variation between arms (dominant or non-dominant) when monitored with the same method on both arms
2: MMG	Device: TOF-Watch SX (neuromuscular monitor) The variation between arms (dominant or non-dominant) when monitored with the same method on both arms

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472121

Locations

Denmark
Dep. of Anaesthesia
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Casper C Kjær, MD

Dep. of anaesthesia 4231, Rigshospitalet

More Information

Study ID Numbers:	MMG-MMG
Study First Received:	May 10, 2007
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00472121
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on January 14, 2009