Performance of Acceleromyography With and Without Preload

Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Device: Hand Adapter (Organon, Oss, the Netherlands); Device: Placebo

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen Ø
    • Copenhagen, Copenhagen Ø, Denmark, 2100
      • Dep. of anesthesia, HOC, Rigshospitalet

Participation Criteria

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Acceleromyography with Hand Adapter on dominant arm	Device: Hand Adapter (Organon, Oss, the Netherlands); 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)
Active Comparator: 2; Acceleromyography with Hand Adapter on non-dominant arm	Device: Hand Adapter (Organon, Oss, the Netherlands); 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)
Placebo Comparator: 3; Acceleromyography without Hand Adapter on dominant arm	Device: Placebo; placebo
Placebo Comparator: 4; Acceleromygraphy without Hand Adapter on non-dominant arm	Device: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The precision of acceleromyography with and without preload during recovery

Secondary Outcome Measures

Outcome Measure
Time to T1=25%
Interval 25-75%
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
Twitch height of T1 at reappearance of T1, T2, T3 and T4
Time to TOF-ratio = 0.9 and 1.0
Time to final T1
Time to final TOF ratio

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion: October 1, 2006

Study Registration Dates

• First Submitted: September 22, 2005
• First Submitted That Met QC Criteria: September 22, 2005
• First Posted (Estimate): September 26, 2005

Study Record Updates

• Last Update Posted (Estimate): April 17, 2008
• Last Update Submitted That Met QC Criteria: April 16, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: AMG01