Comparison of Acceleromyography (AMG) and Mechanomyography (MMG) for Establishing Potency of Neuromuscular Blocking Agents

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00660413
First received: April 15, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Neuromuscular Blockade
Device: TOF-Watch SX (Acceleromyography)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Comparison of ED50 with the two methods

Secondary Outcome Measures:
  • Comparison of ED95 with the two methods

Enrollment: 40
Study Start Date: December 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG
Acceleromygraphy monitoring
Device: TOF-Watch SX (Acceleromyography)
Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.
Active Comparator: MMG
Mechanomyography monitoring
Device: TOF-Watch SX (Acceleromyography)
Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660413

Locations
Denmark
Rigshospitalet
Copenhagen, Østerbro, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Casper Claudius, MD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00660413     History of Changes
Other Study ID Numbers: AMG-MMG D-R
Study First Received: April 15, 2008
Last Updated: April 15, 2008
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Acceleromyography
Mechanomyography
Neuromuscular block
Neuromuscular monitoring
Dose-response
Potency
Rocuronium

Additional relevant MeSH terms:
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014