NCT00226018

Brief Summary

The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

First QC Date

September 22, 2005

Last Update Submit

April 16, 2008

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • The precision of acceleromyography with and without preload during recovery

Secondary Outcomes (11)

  • Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery

  • All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":

  • Bias og limits of agreement between control TOF

  • Onset time

  • Time to reappearance of T1, T2, T3 and T4

  • +6 more secondary outcomes

Study Arms (4)

1

ACTIVE COMPARATOR

Acceleromyography with Hand Adapter on dominant arm

Device: Hand Adapter (Organon, Oss, the Netherlands)

2

ACTIVE COMPARATOR

Acceleromyography with Hand Adapter on non-dominant arm

Device: Hand Adapter (Organon, Oss, the Netherlands)

3

PLACEBO COMPARATOR

Acceleromyography without Hand Adapter on dominant arm

Device: Placebo

4

PLACEBO COMPARATOR

Acceleromygraphy without Hand Adapter on non-dominant arm

Device: Placebo

Interventions

Hand Adapter (Organon, Oss, the Netherlands)DEVICE

Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring)

12
PlaceboDEVICE

placebo

34

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • General anesthesia \> 1 hour
  • Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
  • Written informed content

You may not qualify if:

  • Neuromuscular disorders, hepatic and renal dysfunction
  • Medication expected to interfere with the neuromuscular blocking agent
  • Allergy to any medication used during anesthesia
  • Body weight less or exceeding 20% of the ideal body weight
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of anesthesia, HOC, Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Study Officials

  • Casper C Kjaer, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

March 1, 2005

Study Completion

October 1, 2006

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

DK(1)