Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

NCT03219138 | Completed DMC

• 1 other identifier: N° 1783/ 07
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 5

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

Conditions

Postoperative Residual Curarization

Keywords

muscle function tests

Outcome Measures

Primary Outcomes (1)

• 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

  Muscle function tests are performed immediately after extubation.

Secondary Outcomes (2)

• Uncalibrated acceleromyography

  Uncalibrated acceleromyography is measured immediately after extubation.

• Qualitative neuromuscular measurement

  Qualitative acceleromyography is measured immediately after extubation.

Study Arms (2)

Electromyography

NO INTERVENTION

Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.

Acceleromyography

EXPERIMENTAL

Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.

Device: Acceleromyography

Interventions

Acceleromyography DEVICE

Use of an uncalibrated acceleromyography

Acceleromyography

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• laparoscopic abdominal procedures
• orthopedic
• minor visceral surgery

You may not qualify if:

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

Sponsors & Collaborators

• University of Regensburg: lead
• Technical University of Munich: collaborator
• University Hospital Muenster: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Johannes Gutenberg University Mainz: collaborator

Study Sites (5)

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

Kiel, 24105, Germany

Location

Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster

Münster, 48149, Germany

Location

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

Reutlingen, 72764, Germany

Location

Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock

Rostock, 18057, Germany

Location

Related Publications (5)

• Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.

  PMID: 16183681 BACKGROUND

• Baillard C, Bourdiau S, Le Toumelin P, Ait Kaci F, Riou B, Cupa M, Samama CM. Assessing residual neuromuscular blockade using acceleromyography can be deceptive in postoperative awake patients. Anesth Analg. 2004 Mar;98(3):854-7, table of contents. doi: 10.1213/01.ane.0000100150.84698.8c.

  PMID: 14980952 BACKGROUND

• Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.

  PMID: 17635389 BACKGROUND

• Kotake Y, Ochiai R, Suzuki T, Ogawa S, Takagi S, Ozaki M, Nakatsuka I, Takeda J. Reversal with sugammadex in the absence of monitoring did not preclude residual neuromuscular block. Anesth Analg. 2013 Aug;117(2):345-51. doi: 10.1213/ANE.0b013e3182999672. Epub 2013 Jun 11.

  PMID: 23757472 BACKGROUND

• Unterbuchner C, Blobner M, Puhringer F, Janda M, Bischoff S, Bein B, Schmidt A, Ulm K, Pithamitsis V, Fink H. Development of an algorithm using clinical tests to avoid post-operative residual neuromuscular block. BMC Anesthesiol. 2017 Aug 4;17(1):101. doi: 10.1186/s12871-017-0393-4.

  PMID: 28778151 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Immediately after extubation the blinded anaesthesiologist (care provider), who performs anesthesia, tests the patient in the operating room. The blinded anaesthesiologist is unable to see the data on the EMG monitor and the movement of the adductor pollicis muscle.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: During anaesthesia calibrated neuromuscular function is monitored using evoked EMG of the adductor pollicis muscle (immobilised forearm) with a NMT module by a non-blinded investigator. During surgery, the (blinded) attending anaesthesiologist administers maintenance doses of atracurium according to clinical needs, i.e. without knowing the TOFR. After surgery patients' trachea is extubated according to clinical judgement. Immediately after extubation blinded anaesthesiologist tests the patient. The postoperative evaluation of neuromuscular function consists of eight clinical tests applied in a random order. Thereafter, an uncalibrated acceleromyography (50 mA, 2 Hz) is started on the contralateral arm and TOF ratio is measured. During the validation part of the developed algorithm the anaesthesiologist additionally had to judge tactile fading of the adductor pollicis. If a patient had any clinical signs of neuromuscular dysfunction, reversal with neostigmine is administered.

Study Record Dates

• First Submitted: July 8, 2017
• First Posted: July 17, 2017
• Study Start: January 8, 2008
• Primary Completion: July 25, 2009
• Study Completion: July 25, 2009
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)