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

April 17, 2008 updated by: Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dep. of Anaesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Casper C Kjær, MD, Dep. of anaesthesia 4231, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 10, 2007

First Submitted That Met QC Criteria

May 10, 2007

First Posted (Estimate)

May 11, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2008

Last Update Submitted That Met QC Criteria

April 17, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • MMG-MMG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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