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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660413
• Other study ID #: AMG-MMG D-R
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2008
• Last updated: April 15, 2008
• Start date: December 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• TOF-Watch SX (Acceleromyography)
Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of ED50 with the two methods
Secondary	Comparison of ED95 with the two methods