Comparison of Two Neuromuscular Monitors (NMT-STIMPOD)

January 28, 2015 updated by: University Hospital, Caen
Different neuromuscular monitors may be available in the same care structure. Two different monitors are available in the investigators' institution in the operative room and the recovery room. However, these two monitors have not been compared and may not be interchangeable. Starting the monitoring with one device and continuing with another device may be inaccurate and may lead to inadequate medical decisions. The investigators therefore conducted this observational study to compare the two devices available in our institution.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

17

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Description

Inclusion Criteria:

  • Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Exclusion Criteria:

  • Pregnancy or feeding
  • Any pathology or medication that may impair neuromuscular conduction or muscular response of the ulnar nerve stimulation
  • American Society of Anesthesiology [4] physical status
  • Allergy or contraindication of neuromuscular blocking agents

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recover T4/T1 > 90%
Time Frame: Time between muscle relaxant injection and: intubation; recovery of 4 responses on the train of four (TOF); recovery of T4/T1 >40%; recovery of T4/T1>90% average 2 hours
After muscle relaxant injection, we measure the time needed for the muscular response to disappear and to completely recover during the operation (which takes in average 2 hours).
Time between muscle relaxant injection and: intubation; recovery of 4 responses on the train of four (TOF); recovery of T4/T1 >40%; recovery of T4/T1>90% average 2 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Georges Daccache, M.D, University Hospital, Caen

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

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 13-183

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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