Neuromuscular Block Clinical Trial
Official title:
Evaluation of the New Three-dimensional Acceleromyograph TOF 3D Compared With the Established TOF Watch SX.
NCT number | NCT05005676 |
Other study ID # | TOF 3D |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 31, 2021 |
Est. completion date | August 31, 2022 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients undergoing elective gynecologic surgery requiring general anesthesia and neuromuscular block Exclusion Criteria: - anticipated difficult airway - Risk of pulmonary aspiration - acute infection - pregnancy - renal or hepatic insufficiency - neuromuscular disease - chronic intake of drugs influencing neuromuscular block |
Country | Name | City | State |
---|---|---|---|
Germany | KKH Dormagen | Dormagen |
Lead Sponsor | Collaborator |
---|---|
Kreiskrankenhaus Dormagen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TOF-R 90% | Difference of the 90% train-of-four (TOF) recovery time between both devices | 12 months | |
Secondary | repeatability (precision) | Variance of 10 consecutive measurements around a linear regression line for each device | 12 months | |
Secondary | bias and limits of agreement (Bland-Altman analysis) | Difference between both devices against the average of both measurements (bias +- 2SD) | 12 months |
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