NCT04816539

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

15 days

First QC Date

March 23, 2021

Last Update Submit

March 23, 2021

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Train-of-four ratios

    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 Outcomes (3)

  • Train-of-four ratios

    baseline (J0)

  • Train-of-four ratios

    baseline (J0)

  • Train-of-four count

    baseline (J0)

Interventions

TetraGraphDEVICE

Use of two monitoring devices of neuromuscular function during surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Study Officials

  • Claude Meistelman

    CHU NANCY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claude Meistelman

CONTACT

0383153464c.meistelman@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 15, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations

FR(1)