Comparison of Acceleromyography (AMG) and Mechanomyograph... | NCT00660413

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

NCT00660413

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Apr 17, 2008Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Neuromuscular Blockade

Interventions

TOF-Watch SX (Acceleromyography)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Apr 15, 2008

First Submission Date that Met QC Criteria

Apr 15, 2008

First Posted Date

Apr 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2008

Last Update Posted Date

Apr 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMG	Experimental	Acceleromygraphy monitoring	Device: TOF-Watch SX (Acceleromyography)
MMG	Active Comparator	Mechanomyography monitoring	Device: TOF-Watch SX (Acceleromyography)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TOF-Watch SX (Acceleromyography)	Device	Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.	AMG MMG

Measure	Description	Time Frame
Comparison of ED50 with the two methods

Measure	Description	Time Frame
Comparison of ED95 with the two methods

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Casper Claudius, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen	Østerbro	2100	Denmark