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Comparison of the TOF-Cuff NMT Monitor to the TOF-Watch SX acceleromyograph for perioperative neuromuscular monitoring.


- candidate number28379
- NTR NumberNTR6913
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-dec-2017
- Secondary IDs2017-3858 CMO-code
- Public TitleComparison of the TOF-Cuff NMT Monitor to the TOF-Watch SX acceleromyograph for perioperative neuromuscular monitoring.
- Scientific TitleComparison of the TOF-Cuff NMT Monitor to the TOF-Watch SX acceleromyograph for perioperative neuromuscular monitoring.
- ACRONYM
- hypothesisThe TOF Cuff NMT monitor is as reliable as the TOF-Watch SX acceleromyograph for perioperative neuromuscular monitoring.
- Healt Condition(s) or Problem(s) studiedNeuromuscular monitoring, TOF-Cuff, TOF-Watch
- Inclusion criteria15 patients, age >18 years, American Society of Anesthesiologists physical status I-III, undergoing elective surgery in supine position with both arms abducted, under general anesthesia with orotracheal intubation aided by administration of a non-depolarizing neuromuscular blocking agent.
- Exclusion criteria- No informed consent
- Neuromuscular disease.
- Diabetes Mellitus
- Indication for rapid sequence induction
- Expected difficult intubation or ventilation
- Pregnancy
- Allergy to neuromuscular blocking agent (rocuronium)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-apr-2018
- Target number of participants15
- InterventionsPerioperative neuromuscular monitoring with both the TOF-Cuff NMT Monitor and the TOF-Watch SX acceleromyograph.
- Primary outcomethe bias and limits of agreement of the TOF-Cuff NMT Monitor and the TOF-Watch SX acceleromyograph for perioperative neuromuscular monitoring
- Secondary outcomethe bias and limits of agreement of the TOF-Cuff NMT Monitor and the TOF-Watch SX acceleromyograph for perioperative neuromuscular monitoring?
- TimepointsTime to onset of neuromuscular block is measured for both devices. Onset is defined as time from start of injection until 95% depression of T1. After this paired measurements are taken in all phases of neuromuscular block : the profound/deep phase, in the moderate phase and in the recovery phase. When, during the recovery/progression of the neuromuscular block, the TOF-watch shows a measurement in the range of the next study-measurement the corresponding TOF-cuff value is noted (see table 1.). Because both devices will measure every 30 seconds the maximal time between two measurements of both devices is 15 seconds. In each predefined range of neuromuscular relaxation 3 measurements will be taken to correct for slight variations of the measurements in each device.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES P. Krijtenburg
- CONTACT for SCIENTIFIC QUERIES P. Krijtenburg
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-dec-2017 - 5-jan-2018


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