Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

N/ACompletedNCT03219138

University of Regensburg265 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

265

Conditions

Postoperative Residual Curarization

Interventions

AcceleromyographyDEVICE

Use of an uncalibrated acceleromyography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Kiel, Germany

Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster

Münster, Germany

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

Outcomes

Primary Outcomes

Clinical muscle function tests

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

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

Secondary Outcomes

Uncalibrated acceleromyography

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

Time frame: Uncalibrated acceleromyography is measured immediately after extubation.

Qualitative neuromuscular measurement

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

Time frame: Qualitative acceleromyography is measured immediately after extubation.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.