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Accelerometry at the Neck: Comparison With m. Adductor Pollicis Stimulation

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ClinicalTrials.gov Identifier: NCT01849198
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Kreiskrankenhaus Dormagen

Brief Summary:

Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed at the M. adductor pollicis. However, many operations require positioning of the patients with arms attached to the body. In these situations, the anaesthesiologist has no access to the m.adductor pollicis.

In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the n. accessorius with accelerometry of the m. trapezius.


Condition or disease Intervention/treatment Phase
Feasibility of Measurement of a Neuromuscular Block at the m. Trapezius Device: accelerometry m. trapezius and m. adductor pollicis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Group trapezius
Assessment of intubation conditions after onset of the neuromuscular block at the m. trapezius
Device: accelerometry m. trapezius and m. adductor pollicis
group adductor pollicis
assessment of intubation conditions after onset of the neuromuscular block at the m. adductor pollicis
Device: accelerometry m. trapezius and m. adductor pollicis



Primary Outcome Measures :
  1. Recovery to a train of four ratio of 0.9 [ Time Frame: 60 minutes ]
    Comparison between time to recovery [s] to a train of four ratio of 0.9 between both groups


Secondary Outcome Measures :
  1. onset of neuromuscular block [ Time Frame: 10 min ]
    Comparison of onset time [s] between both groups. Onset time is defined as decrease of T1 to < 5% of initial twitch height.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing general anaesthesia with endotracheal intubation
  • weight 50-90 kg

Exclusion Criteria:

  • Pregnancy
  • allergy to one of the drugs used
  • risk of pulmonary aspiration
  • expected difficulties with endotracheal intubation
  • intake of drugs known to influence neuromuscular block
  • infection (CRP > 0,5 mg/dl, leukocyte count > 12000/µl)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849198


Locations
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Germany
KKH Dormagen
Dormagen, Germany, 41540
Sponsors and Collaborators
Kreiskrankenhaus Dormagen