NCT00660413

Brief Summary

The purpose of this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized that there would be no significant difference between potencies estimated using acceleromyography and mechanomyography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

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

December 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

2 months

First QC Date

April 15, 2008

Last Update Submit

April 15, 2008

Conditions

Neuromuscular Blockade

Keywords

AcceleromyographyMechanomyographyNeuromuscular blockNeuromuscular monitoringDose-responsePotencyRocuronium

Outcome Measures

Primary Outcomes (1)

  • Comparison of ED50 with the two methods

Secondary Outcomes (1)

  • Comparison of ED95 with the two methods

Study Arms (2)

AMG

EXPERIMENTAL

Acceleromygraphy monitoring

Device: TOF-Watch SX (Acceleromyography)

MMG

ACTIVE COMPARATOR

Mechanomyography monitoring

Device: TOF-Watch SX (Acceleromyography)

Interventions

TOF-Watch SX (Acceleromyography)DEVICE

Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.

AMGMMG

Eligibility Criteria

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

You may qualify if:

  • ASA I-III
  • Ideal weight +/-20%
  • Both arms available for neuromuscular monitoring
  • Surgery in supine position
  • Participated surgery time more than 30 min

You may not qualify if:

  • Pregnant and breast-feeding women
  • Patients with known illness or use of medications known to influence the neuromuscular transmission
  • Known significant renal or hepatic dysfunction
  • Allergy to medications used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

Study Officials

  • Casper Claudius, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

DK(1)