- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02350062
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
Conditions
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.
Sponsor
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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