Evaluation of the New Three-dimensional Acceleromyograph TOF 3D Compared With the Established TOF Watch SX.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Assessment of a New Acceleromyograph
- Sponsor
- Kreiskrankenhaus Dormagen
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- TOF-R 90%
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Stefan Soltesz
Prof. Dr. Stefan Soltesz
Kreiskrankenhaus Dormagen
Eligibility Criteria
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
Outcomes
Primary Outcomes
TOF-R 90%
Time Frame: 12 months
Difference of the 90% train-of-four (TOF) recovery time between both devices
Secondary Outcomes
- repeatability (precision)(12 months)
- bias and limits of agreement (Bland-Altman analysis)(12 months)