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

September 5, 2016 updated by: Kreiskrankenhaus Dormagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dormagen, Germany, 41540
        • KKH Dormagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group trapezius
Assessment of intubation conditions after onset of the neuromuscular block at the m. trapezius
Device: accelerometry m. trapezius and m. adductor pollicis
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kreiskrankenhaus Dormagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NMMneck

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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