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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2022
Source Kreiskrankenhaus Dormagen
Contact Stefan Soltesz, Prof.
Phone 00492133664500
Email stefan.soltesz@kkh-ne.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
acceleromyography
Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs

Locations

Country Name City State
Germany KKH Dormagen Dormagen

Sponsors (1)

Lead Sponsor Collaborator
Kreiskrankenhaus Dormagen

Country where clinical trial is conducted

Germany, 

Outcome

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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