Feasibility of Measurement of a Neuromuscular Block at the m. TrapeziusNCT01849198
Accelerometry at the Neck: Comparison With m. Adductor Pollicis Stimulation
A study testing accelerometry m. trapezius and m. adductor pollicis in people with Feasibility of Measurement of a Neuromuscular Block at the m. Trapezius, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Feasibility of Measurement of a Neuromuscular Block at the m. Trapezius
- What is being tested?
- accelerometry m. trapezius and m. adductor pollicis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing general anaesthesia with endotracheal intubation
- weight 50-90 kg
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- accelerometry m. trapezius and m. adductor pollicis
- Keywords
- accelerometry, neuromuscular block, m. trapezius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerometry m. trapezius and m. adductor pollicisDevice
| Study group | Role | What they receive |
|---|---|---|
| Group trapezius | Other | Assessment of intubation conditions after onset of the neuromuscular block at the m. trapezius Receives: Device: accelerometry m. trapezius and m. adductor pollicis |
| group adductor pollicis | Other | assessment of intubation conditions after onset of the neuromuscular block at the m. adductor pollicis Receives: Device: accelerometry m. trapezius and m. adductor pollicis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery to a train of four ratio of 0.9
Comparison between time to recovery [s] to a train of four ratio of 0.9 between both groups
Measured: 60 minutes
Secondary outcomes (1)
onset of neuromuscular block
Comparison of onset time [s] between both groups. Onset time is defined as decrease of T1 to < 5% of initial twitch height.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feasibility of Measurement of a Neuromuscular Block at the m. TrapeziusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kreiskrankenhaus Dormagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849198
- Sponsor's protocol ID
- NMMneck
- Status last verified
- Sep 2016
- First submitted
- 29 Apr 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Soltesz S, Stark C, Noe KG, Anapolski M, Mencke T. Comparison of the trapezius and the adductor pollicis muscle as predictor of good intubating conditions: a randomized controlled trial. BMC Anesthesiol. 2017 Aug 17;17(1):106. doi: 10.1186/s12871-017-0401-8.
PubMed 28818054Soltesz S, Stark C, Noe KG, Anapolski M, Mencke T. Monitoring recovery from rocuronium-induced neuromuscular block using acceleromyography at the trapezius versus the adductor pollicis muscle: an observational trial. Can J Anaesth. 2016 Jun;63(6):709-17. doi: 10.1007/s12630-016-0609-y. Epub 2016 Feb 10.
PubMed 26864194
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometry at the Neck: Comparison With m. Adductor Pollicis Stimulation
- ClinicalTrials.gov ID
- NCT01849198
- Acronym / sponsor ID
- NMMneck
- Keywords
- accelerometry, neuromuscular block, m. trapezius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kreiskrankenhaus DormagenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group trapezius | Other | Device: accelerometry m. trapezius and m. adductor pollicisAssessment of intubation conditions after onset of the neuromuscular block at the m. trapezius |
| group adductor pollicis | Other | Device: accelerometry m. trapezius and m. adductor pollicisassessment of intubation conditions after onset of the neuromuscular block at the m. adductor pollicis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing general anaesthesia with endotracheal intubation
- weight 50-90 kg
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accelerometry m. trapezius and m. adductor pollicis | Device | Group trapezius, group adductor pollicis |
Primary outcome
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
1 secondary outcome
onset of neuromuscular block
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 28818054Soltesz S, Stark C, Noe KG, Anapolski M, Mencke T. Comparison of the trapezius and the adductor pollicis muscle as predictor of good intubating conditions: a randomized controlled trial. BMC Anesthesiol. 2017 Aug 17;17(1):106. doi: 10.1186/s12871-017-0401-8.
- Derived from this study: PubMed 26864194Soltesz S, Stark C, Noe KG, Anapolski M, Mencke T. Monitoring recovery from rocuronium-induced neuromuscular block using acceleromyography at the trapezius versus the adductor pollicis muscle: an observational trial. Can J Anaesth. 2016 Jun;63(6):709-17. doi: 10.1007/s12630-016-0609-y. Epub 2016 Feb 10.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accelerometry m. trapezius and m. adductor pollicis in people with Feasibility of Measurement of a Neuromuscular Block at the m. Trapezius, run by Kreiskrankenhaus Dormagen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery to a train of four ratio of 0.9 (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849198, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016; AzTrials last refreshed its copy on 31 Oct 2026.