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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660413
First Posted: April 17, 2008
Last Update Posted: April 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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
Masking: Single
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660413


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

ClinicalTrials.gov Identifier: NCT00660413     History of Changes
Other Study ID Numbers: AMG-MMG D-R
First Submitted: April 15, 2008
First Posted: April 17, 2008
Last Update Posted: April 17, 2008
Last Verified: April 2008

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