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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014