NCT00660413CompletedPhase 4
Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study
Rigshospitalet, Denmark1 site in 1 country40 target enrollmentStarted: December 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Comparison of ED50 with the two methods
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AMG
Experimental
Acceleromygraphy monitoring
Intervention: TOF-Watch SX (Acceleromyography) (Device)
MMG
Active Comparator
Mechanomyography monitoring
Intervention: TOF-Watch SX (Acceleromyography) (Device)
Outcomes
Primary Outcomes
Comparison of ED50 with the two methods
Secondary Outcomes
- Comparison of ED95 with the two methods
Investigators
Study Sites (1)
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