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Performance of Acceleromyography With and Without Preload

Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00226018
Enrollment
60
Registered
2005-09-26
Start date
2005-03-31
Completion date
2006-10-31
Last updated
2008-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

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.

Interventions

DEVICEHand 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)

DEVICEPlacebo

placebo

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The precision of acceleromyography with and without preload during recovery

Secondary

MeasureTime frame
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
Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
Interval 25-75%
Time to TOF-ratio = 0.9 and 1.0
Time to final T1
Time to final TOF ratio
Time to T1=25%

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026