Evaluation of the New Acceleromyograph TOF 3D

Not Applicable

• Conditions: Assessment of a New Acceleromyograph; Neuromuscular Block

• Registration Number: NCT05005676
• Lead Sponsor: Kreiskrankenhaus Dormagen

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.

Study Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-13
• Study Start: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TOF-R 90%	12 months	Difference of the 90% train-of-four (TOF) recovery time between both devices

Secondary Outcome Measures

Name	Time	Method
repeatability (precision)	12 months	Variance of 10 consecutive measurements around a linear regression line for each device
bias and limits of agreement (Bland-Altman analysis)	12 months	Difference between both devices against the average of both measurements (bias +- 2SD)

Trial Locations

Locations (1)

KKH Dormagen; 🇩🇪 Dormagen, Germany