Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

Postoperative Residual Curarization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219138
• Other study ID #: N° 1783/ 07
• Status: Completed
• Phase: N/A
• First received: July 8, 2017
• Last updated: July 12, 2017
• Start date: January 8, 2008
• Est. completion date: July 25, 2009

Study information

• Verified date: July 2017
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: July 25, 2009
• Est. primary completion date: July 25, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Postoperative Residual Curarization

Intervention

Device:
• Acceleromyography
Use of an uncalibrated acceleromyography

Locations

Country	Name	City	State
Germany	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	Reutlingen
Germany	Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock	Rostock

Sponsors (5)

Lead Sponsor	Collaborator
University of Regensburg	Johannes Gutenberg University Mainz, Technische Universität München, University Hospital Muenster, University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. Epub 2005 Sep 23. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uncalibrated acceleromyography	Contralateral to the electromyography arm an uncalibrated acceleremyography measures objectively postoperative residual curarisation by examination of the train of four ratio.	Uncalibrated acceleromyography is measured immediately after extubation.
Secondary	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.	Qualitative acceleromyography is measured immediately after extubation.