Postoperative Residual Curarization
Conditions
Keywords
muscle function tests
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.
Interventions
DEVICEAcceleromyography
Use of an uncalibrated acceleromyography
Sponsors
Technical University of Munich
University Hospital Muenster
University Hospital Schleswig-Holstein
Johannes Gutenberg University Mainz
University of Regensburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed