Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

Not Applicable

Completed

• Conditions: Postoperative Residual Curarization
• Interventions: Device: Acceleromyography

• Registration Number: NCT03219138
• Lead Sponsor: University of Regensburg

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-01-08
• Primary Completion: 2009-07-25
• Study Completion: 2009-07-25
• Status Verified: 2017-07
• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-17
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

The patients were scheduled for elective low risk surgical procedures:

• laparoscopic abdominal procedures
• orthopedic
• minor visceral surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acceleromyography	Acceleromyography	Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.

Primary Outcome Measures

Name	Time	Method
Clinical muscle function tests	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 Outcome Measures

Name	Time	Method
Uncalibrated acceleromyography	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.
Qualitative neuromuscular measurement	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.

Trial Locations

Locations (5)

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

Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock; 🇩🇪 Rostock, Germany

Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany; 🇩🇪 Reutlingen, Germany