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Safety and Feasibility of a New Neuromuscular Monitoring Device

NCT ID: NCT03847740

Last Updated: 2019-10-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2019-08-22

Brief Summary

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The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.

The two devices will be studied simultaneously in each patient.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Right Isometric Thumb Force (ITF) handle

Group Type EXPERIMENTAL

Isometric Trumb Force handle

Intervention Type DEVICE

Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.

Left Isometric Thumb Force (ITF) handle

Group Type EXPERIMENTAL

Isometric Trumb Force handle

Intervention Type DEVICE

Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.

Interventions

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Isometric Trumb Force handle

Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients,
* ASA class 1 to 3,
* Scheduled for elective surgery requiring general anesthesia and muscle paralysis

Exclusion Criteria

* Age inferior to 18 years,
* ASA class 4,
* Emergency surgery,
* Prone position on the operating table
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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MONITOF

Identifier Type: -

Identifier Source: org_study_id