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

April 15, 2008 updated by: Rigshospitalet, Denmark

Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Østerbro
      • Copenhagen, Østerbro, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of ED50 with the two methods

Secondary Outcome Measures

Outcome Measure
Comparison of ED95 with the two methods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Casper Claudius, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (ESTIMATE)

April 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMG-MMG D-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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