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The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX.
The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX. The time course of a neuromuscular block (onset, maximal block, time to recovery) is assessed simultaneously with both devices in 50 patients undergoing elective gynecologic surgery requiring neuromuscular block. The validity and reliability of the new technique is evaluated with a Bland-Altman- analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adductor pollicis AP | Experimental | Measurement site: M.adductor pollicis of both arms. |
|
| Corrugator supercilii CS | Experimental | Measurement site: M. corrugator supercilii at both sides |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acceleromyography | Diagnostic Test | Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs |
|
| Measure | Description | Time Frame |
|---|---|---|
| TOF-R 90% | Difference of the 90% train-of-four (TOF) recovery time between both devices | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| repeatability (precision) | Variance of 10 consecutive measurements around a linear regression line for each device | 12 months |
| bias and limits of agreement (Bland-Altman analysis) | Difference between both devices against the average of both measurements (bias +- 2SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Soltesz, Prof. | Contact | 00492133664500 | stefan.soltesz@kkh-ne.de | |
| Günter K Noe, MD | Contact | 00492133664600 | karl-guenter.noe@kkh-ne.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KKH Dormagen | Recruiting | Dormagen | D-41540 | Germany |
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| 12 months |