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Evaluation of the New Acceleromyograph TOF 3D

Evaluation of the New Three-dimensional Acceleromyograph TOF 3D Compared With the Established TOF Watch SX.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05005676
Enrollment
50
Registered
2021-08-13
Start date
2021-08-31
Completion date
2022-08-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment of a New Acceleromyograph, Neuromuscular Block

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.

Interventions

DIAGNOSTIC_TESTacceleromyography

Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs

Sponsors

Kreiskrankenhaus Dormagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TOF-R 90%12 monthsDifference of the 90% train-of-four (TOF) recovery time between both devices

Secondary

MeasureTime frameDescription
bias and limits of agreement (Bland-Altman analysis)12 monthsDifference between both devices against the average of both measurements (bias +- 2SD)
repeatability (precision)12 monthsVariance of 10 consecutive measurements around a linear regression line for each device

Countries

Germany

Contacts

Primary ContactStefan Soltesz, Prof.
stefan.soltesz@kkh-ne.de00492133664500
Backup ContactGünter K Noe, MD
karl-guenter.noe@kkh-ne.de00492133664600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026