Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.
Primary Purpose
Postoperative Residual Curarization
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acceleromyography
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Residual Curarization focused on measuring muscle function tests
Eligibility Criteria
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.
Sites / Locations
- 6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,
- Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster
- Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany
- Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Electromyography
Acceleromyography
Arm Description
Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.
Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Uncalibrated acceleromyography
Contralateral to the electromyography arm an uncalibrated acceleremyography measures objectively postoperative residual curarisation by examination of the train of four ratio.
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.
Full Information
NCT ID
NCT03219138
First Posted
July 8, 2017
Last Updated
July 12, 2017
Sponsor
University of Regensburg
Collaborators
Technical University of Munich, University Hospital Muenster, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT03219138
Brief Title
Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.
Official Title
Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2008 (Actual)
Primary Completion Date
July 25, 2009 (Actual)
Study Completion Date
July 25, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
Collaborators
Technical University of Munich, University Hospital Muenster, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Residual Curarization
Keywords
muscle function tests
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
Care Provider
Masking Description
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.
Allocation
Non-Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromyography
Arm Type
No Intervention
Arm Description
Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.
Arm Title
Acceleromyography
Arm Type
Experimental
Arm Description
Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.
Intervention Type
Device
Intervention Name(s)
Acceleromyography
Intervention Description
Use of an uncalibrated acceleromyography
Primary Outcome Measure Information:
Title
Clinical muscle function tests
Description
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 Outcome Measure Information:
Title
Uncalibrated acceleromyography
Description
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.
Title
Qualitative neuromuscular measurement
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16183681
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. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.
Results Reference
background
PubMed Identifier
14980952
Citation
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.
Results Reference
background
PubMed Identifier
17635389
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. doi: 10.1111/j.1399-6576.2007.01352.x.
Results Reference
background
PubMed Identifier
23757472
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.
Results Reference
background
PubMed Identifier
28778151
Citation
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.
Results Reference
derived
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Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.
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