NCT01849198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

April 29, 2013

Last Update Submit

September 5, 2016

Conditions

Keywords

accelerometryneuromuscular blockm. trapezius

Outcome Measures

Primary Outcomes (1)

  • 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

    60 minutes

Secondary Outcomes (1)

  • onset of neuromuscular block

    10 min

Study Arms (2)

Group trapezius

OTHER

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

OTHER

assessment of intubation conditions after onset of the neuromuscular block at the m. adductor pollicis

Device: accelerometry m. trapezius and m. adductor pollicis

Interventions

Group trapeziusgroup adductor pollicis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKH Dormagen

Dormagen, 41540, Germany

Location

Related Publications (2)

  • 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.

  • Soltesz 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 8, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations