Evaluation of the New Acceleromyograph TOF 3D

NCT ID: NCT05005676

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Assessment of a New Acceleromyograph Neuromuscular Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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adductor pollicis AP

Measurement site: M.adductor pollicis of both arms.

Group Type EXPERIMENTAL

acceleromyography

Intervention Type DIAGNOSTIC_TEST

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

Corrugator supercilii CS

Measurement site: M. corrugator supercilii at both sides

Group Type EXPERIMENTAL

acceleromyography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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acceleromyography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kreiskrankenhaus Dormagen

OTHER

Sponsor Role lead

Responsible Party

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Stefan Soltesz

Prof. Dr. Stefan Soltesz

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KKH Dormagen

Dormagen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Soltesz, Prof.

Role: CONTACT

00492133664500

Günter K Noe, MD

Role: CONTACT

00492133664600

Facility Contacts

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Soltesz, MD

Role: primary

0049 2133 66 4500

Other Identifiers

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TOF 3D

Identifier Type: -

Identifier Source: org_study_id

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