Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation (DBS PREDICTION)

September 2, 2016 updated by: Central Hospital, Nancy, France
The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery:

  • T4/T1 ratio: ratio between the 4th and 1st response to "train of four" stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is > 0.9
  • Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms.

It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is > 0.6. However, for an optimal recovery, T4/T1 ratio must be > 0.9.

This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation.

Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Locations

  • France
      • Vandoeuvre Les Nancy, France
        • Recruiting
        • CHRU Nancy

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

Non-Probability Sample

Study Population

Patient curarised at Nancy Hospital

Description

Inclusion Criteria:

  • ASA score 1-3
  • Needing a surgery with tracheal intubation curarisation

Exclusion Criteria:

  • none

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Curarized patients
Procedure: Surgery with tracheal intubation curarisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9
Time Frame: day 0
measured with TOF-Watch Sx
day 0

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Denis Schmartz, CHRU Nancy, France

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

April 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PSS2014/DBSPREDICTION-SCHMARTZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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