NCT00472121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 18, 2008

Status Verified

April 1, 2008

Enrollment Period

5 months

First QC Date

May 10, 2007

Last Update Submit

April 17, 2008

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1: AMG

Device: TOF-Watch SX (neuromuscular monitor)

2: MMG

Device: TOF-Watch SX (neuromuscular monitor)

Interventions

TOF-Watch SX (neuromuscular monitor)DEVICE

The variation between arms (dominant or non-dominant) when monitored with the same method on both arms

1: AMG2: MMG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anaesthesia

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Claudius C, Skovgaard LT, Viby-Mogensen J. Arm-to-arm variation when evaluating neuromuscular block: an analysis of the precision and the bias and agreement between arms when using mechanomyography or acceleromyography. Br J Anaesth. 2010 Sep;105(3):310-7. doi: 10.1093/bja/aeq162. Epub 2010 Jun 30.

    PMID: 20595196DERIVED

Study Officials

  • Casper C Kjær, MD

    Dep. of anaesthesia 4231, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

April 18, 2008

Record last verified: 2008-04

Locations

DK(1)