Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function (DECURAR-EMG)

March 23, 2021 updated by: Central Hospital, Nancy, France

Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function : a Pilot Study

Assess the values of train-of-four ratios with the TetraGraph and thoses obtained with the TOFscan during recovery of neuromusculat function in surgical patients who have been administred rocuronium.

Primary outcome : value of TOFratio with the TetraGraph when TOFratio of TOFscan is greater than or equal to 90% Pilot study : no hypothesis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing an electrive surgical procedure with non emergency and that requires use of Rocuronium, and willing to participate and provide an informed consent

Description

Inclusion Criteria:

  • age greater than or equal to 18 years old
  • patients willing to participate and provide an informed consent
  • elective surgical procedures, without emergency, administration of rocuronium for neuromuscular blockade, and recovery of complete neuromuscular function at the end of the surgery

Exclusion Criteria:

  • patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or similar wrist injury
  • patients with systemic neuromuscular diseases such as myasthenia gravis
  • renal insufficiency or renal failure
  • significant liver disease
  • patients having surgery that would involve prepping the arm into the sterile field
  • allergy to rocuronium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Train-of-four ratios
Time Frame: baseline (J0)
Value of TOFratio with TetraGraph when TOFratio with TOFscan is greater than or equal to 90% (first value of three greater than or equal to 90%)
baseline (J0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Train-of-four ratios
Time Frame: baseline (J0)
Value of TOFratio with TetraGraph when TOFratio with TOFscan is greater than or equal to 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and eventually 100%
baseline (J0)
Train-of-four ratios
Time Frame: baseline (J0)
Value of TOFratio with TOFscan when TOFratio with TetraGraph is greater than or equal to 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and eventually 100%
baseline (J0)
Train-of-four count
Time Frame: baseline (J0)
Time to recover one, two, three and four responses from TOFcount with TOFscan and TetraGraph
baseline (J0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Claude Meistelman, CHU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2021

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A03054-35

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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