Neuromuscular Blockade
Conditions
Brief summary
Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block during anesthesia. However AMG is known to be inaccurate when compared to the gold standard in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the patients arms require to be positioned next to the body and beneath surgical drapes, AMG measurements are often hindered and inaccurate. The TOF cuff is a new device which measures neuromuscular blockade at the upper arm with a blood pressure cuff. It overcomes the previously mentioned disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been investigated. This study aims to compare the bias, limits of agreement and precision of the Train-of-Four cuff relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients with normal body mass index and morbidly obese patients.
Interventions
DIAGNOSTIC_TESTMeasurements of the level of neuromuscular blockade
Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.
Sponsors
Merck Sharp & Dohme LLC
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American society of Anesthesiologist Physical Status class I-III * \>18 years of age * Ability to give oral and written informed consent
Exclusion criteria
* Known or suspected neuromuscular disorders impairing neuromuscular function; * Allergies to muscle relaxants, anesthetics or narcotics; * A (family) history of malignant hyperthermia; * Women who are or may be pregnant or are currently breast feeding; * Renal insufficiency, as defined by a glomerular filtration rate \< 30 ml/min * Scheduled for anesthesia without the use of muscle relaxants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below | Depth of as neuromuscular block will be compared between the Tof-Cuff and electromography at five minute intervals during moderate neuromuscular blockade. Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis). This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects. Bland-Altman analysis estimates bias and limits of agreement (95% differences between compared devices) between Tof-Cuff and electromography and evaluates instrumental imprecision by calculating the repeatability coefficient, which is equal to the standard deviation of the within-subject variability of each device. For interpretation of the Bland-Altman bias during offset of neuromuscular blockade one can assume that a bias above zero indicates that TOF-Cuff overestimates neuromuscular blockade recovery whilst a bias below zero indicates that Tof-Cuff underestimates neuromuscular blockade recovery. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate Neuromuscular Block, Normal Body Mass Index Patients recruited in the Leiden University Medical Centre with a normal body mass index (18-30) Train of four ratios are collected during moderate neuromuscular blockade. | 148 |
| Deep Neuromuscular Block, Normal Body Mass Index Patients recruited in the Leiden University Medical Centre with a normal body mass index (18-30) Post tetanic counts are collected during deep neuromuscular blockade | 52 |
| Moderate Neuromuscular Block, High Body Mass Index Measurements during deep neuromuscular block in Patients recruited in the Dutch Obesity Clinic with a high body mass index (\>30) Train of four ratios are collected during moderate neuromuscular blockade. | 21 |
| Deep Neuromuscular Block, High Body Mass Index Measurements during deep neuromuscular block in Patients recruited in the Dutch Obesity Clinic with a high body mass index (\>30) Post tetanic counts are collected during deep neuromuscular blockade | 29 |
| Total | 250 |
Baseline characteristics
| Characteristic | Moderate Neuromuscular Block, Normal Body Mass Index | Deep Neuromuscular Block, Normal Body Mass Index | Moderate Neuromuscular Block, High Body Mass Index | Deep Neuromuscular Block, High Body Mass Index | Total |
|---|---|---|---|---|---|
| Age, Continuous | 57 years | 51 years | 45 years | 47 years | 55 years |
| Count of participants | 148 Participants | 52 Participants | 21 Participants | 29 Participants | 250 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 86 Participants | 25 Participants | 12 Participants | 23 Participants | 146 Participants |
| Sex: Female, Male Male | 62 Participants | 27 Participants | 9 Participants | 6 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 0 / 52 | 0 / 21 | 0 / 29 |
| other Total, other adverse events | 13 / 148 | 7 / 52 | 0 / 21 | 0 / 29 |
| serious Total, serious adverse events | 7 / 148 | 3 / 52 | 0 / 21 | 0 / 29 |
Outcome results
Primary
Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count)
Depth of as neuromuscular block will be compared between the Tof-Cuff and electromography at five minute intervals during moderate neuromuscular blockade. Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis). This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects. Bland-Altman analysis estimates bias and limits of agreement (95% differences between compared devices) between Tof-Cuff and electromography and evaluates instrumental imprecision by calculating the repeatability coefficient, which is equal to the standard deviation of the within-subject variability of each device. For interpretation of the Bland-Altman bias during offset of neuromuscular blockade one can assume that a bias above zero indicates that TOF-Cuff overestimates neuromuscular blockade recovery whilst a bias below zero indicates that Tof-Cuff underestimates neuromuscular blockade recovery.
Time frame: at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below
Population: The outcome measurement data indicates the difference between both devices (TOF-Cuff versus electromography) of either train of four measurements or post tetanic count measurements . Bias is a unitless number and therefore the number option is chosen as measurement type. It is neither a ratio, median or mean. The bias is zero when there is no difference between measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate Neuromuscular Block, Normal Body Mass Index | Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | train-of-four ratio | 0.312 bias |
| Deep Neuromuscular Block, Normal Body Mass Index | Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | post-tetanic-count | 3.405 bias |
| Moderate Neuromuscular Block, High Body Mass Index | Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | train-of-four ratio | 0.384 bias |
| Deep Neuromuscular Block, High Body Mass Index | Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) | post-tetanic-count | -0.17 bias |
Comparison: Paired measurements were compared using a Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis, Leiden, the Netherlands).~This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects.0.05% CI: [-0.05, 0.05]