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Completed

NCT Number: NCT03219138

Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

Objective neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function tests to identify PORC

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Key information

Conditions

Postoperative Residual Curarization Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,, Kiel, Germany

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About this study

Background: Quantitative neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive, qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre, prospective, double-blinded, assessor controlled study is to develop an algorithm of muscle function tests to identify PORC.

Methods: After extubation a blinded anesthetist performs eight clinical tests in 165 patients. Test results are correlated to calibrated electromyography train-of-four (TOF) ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and regression tree (CART) is calculated developing the algorithm to identify PORC. This is validated against uncalibrated acceleromyography and tactile judgement of TOF fading in separate 100 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patients were scheduled for elective low risk surgical procedures:

  • laparoscopic abdominal procedures
  • orthopedic
  • minor visceral surgery

Exclusion criteria

  • participation in another study
  • body mass index over 30
  • history of neuromuscular diseases
  • gastro-esophageal reflux disease.

Treatment and study plan

Acceleromyography

Device

Use of an uncalibrated acceleromyography

Primary outcomes

  1. Clinical muscle function tests

    Time frame: Muscle function tests are performed immediately after extubation.

    Measurement of postoperative residual curarisation with clinical muscle function test:

    • time able to open the eyes
    • appearence of diplopic images
    • time able to stick out the tongue
    • spatula pressure test
    • time able to lift the head
    • time able to lift the arm
    • strength of the patient pressing the investigator's hand
    • ability to swallow 20 ml of water

Secondary outcomes

  1. Uncalibrated acceleromyography

    Time frame: Uncalibrated acceleromyography is measured immediately after extubation.

    Contralateral to the electromyography arm an uncalibrated acceleremyography measures objectively postoperative residual curarisation by examination of the train of four ratio.

  2. Qualitative neuromuscular measurement

    Time frame: Qualitative acceleromyography is measured immediately after extubation.

    Contralateral to the electromyography arm qualitative tactile judgement of the train of four stimulation was measured by acceleremyography to scale postoperative residual curarisation.

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Collaborators

  • Johannes Gutenberg University Mainz
  • Technical University of Munich
  • University Hospital Muenster
  • University Hospital Schleswig-Holstein

Registry information

Official study title

Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 17, 2017
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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