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OS NMB Depth Measured by Central and Peripheral Monitor.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660891
Recruitment Status : Unknown
Verified March 2020 by Jan Mulier, AZ Sint-Jan AV.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jan Mulier, AZ Sint-Jan AV

Study Description
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Brief Summary:
Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.

Condition or disease Intervention/treatment
Neuromuscular Blockade Diagnostic Test: measuring neuromuscular block

Detailed Description:

NMT (neuromuscular transmission) depth can be measured at the same arm with two different methods during clinical practice.

the first (TOF Watch) measures the musculus adductor pollicis acceleration while the second method (TOF Cuff Monitor) uses a blood pressure cuff to measure the pressure changes induced by the upper arm muscles.

During general anesthesia when NMB (neuromuscular block) is required both methods are used. Every 5 minutes, if clinical required, the NMB is monitored by TOF-PTC. If the measurement of TOF is zero the monitor continues by measuring PTC ( the system will measure TOF followed by PTC if TOF is zero) TOF-PTC is recorded and later compared for identity or systematic difference in one or the other direction.

The measured answer can be TOF 4 (4 answers) with a ratio between answer 1 and 4 expressed and a percentage, TOF 3 (3 answers), TOF 2, TOF 1, TOF 0 + PTC 20, TOF 0 + PTC 19, up to TOF 0 + PTC 0

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study Measuring Neuromuscular Block Depth by a TOF or PTC Monitor on the Thumb and on the Upper Arm of the Same Side.
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: measuring neuromuscular block
    During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared

Outcome Measures
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Primary Outcome Measures :
  1. TOF-PTC value [ Time Frame: From induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in duration ]
    Difference in TOF-PTC measured by two different devices during anesthesia.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients undergo a laparoscopic surgery and require a deep NMB.
Criteria

Inclusion Criteria: all patients scheduled for an elective surgery requiring neuromuscular block during anesthesia

  • laparoscopic surgery of upper abdomen including all types of bariatric surgery.

Exclusion Criteria: not possible to measure NMT (neuromuscular transmission) by cuff or thumb monitor

  • upper arm obesity excluding the use of an upper arm blood pressure cuff
  • allergy to NMB (neuromuscular blockers)
  • contra indication for a deep NMB
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660891


Contacts
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Contact: Jan Paul Mulier, PhD 003259452490 jan.mulier@azsintjan.be
Contact: Kris Leleu, MD 003250452490

Locations
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Belgium
Azsintjan
Brugge, Belgium, 8000
Contact: j p mulier, MD PhD    00 32 50 45 21 93    anesthesie@azsintjan.be   
Principal Investigator: jan P mulier, PhD         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Jan Paul Mulier AZSint Jan AV
More Information
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Responsible Party: Jan Mulier, principle investigator, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03660891    
Other Study ID Numbers: OS NMBcentralperipheral
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No