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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 10, 2007

Last Updated Date

April 17, 2008

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00472121 on ClinicalTrials.gov Archive Site

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Observational

Study Design ^†

Condition ^†

Neuromuscular Blockade

Intervention ^†

Device: TOF-Watch SX (neuromuscular monitor)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472121

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Rigshospitalet, Denmark

Collaborators ^††

Investigators ^†

Principal Investigator:

Casper C Kjær, MD

Dep. of anaesthesia 4231, Rigshospitalet

Information Provided By

Rigshospitalet, Denmark

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.