The TOF cuff behaves similarly to EMG in terms of bias, limits of agreement and precision when comparing the TOF cuff to EMG.
ID
Bron
Verkorte titel
Aandoening
N.A.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
TOF and TOF ratio values differences between both groups
Achtergrond van het onderzoek
This is an observational, non-inferiority trial in which we will compare the TOF cuff device to electromyography (EMG). All patients will receive general anesthesia (with rocuronium). Patients will have the TOF cuff and EMG placed on the same or extremity (hand for EMG, upper arm for TOF cuff). Measurements will be done during inthe entire procedure. We will perform a pilot study with 250 patients to ensure that reliable estimates of repeatability coefficient, bias, and limits of agreement are obtained.
Doel van het onderzoek
The TOF cuff behaves similarly to EMG in terms of bias, limits of agreement and precision when comparing the TOF cuff to EMG.
Onderzoeksopzet
N.A.
Onderzoeksproduct en/of interventie
N.A.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(i) ASA class I-III
(ii) > 18 years of age;
(iii) Ability to give oral and written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(i) Known or suspected neuromuscular disorders impairing neuromuscular function;
(ii) Allergies to muscle relaxants, anesthetics or narcotics;
(iii) A (family) history of malignant hyperthermia;
(iv) Women who are or may be pregnant or are currently breast feeding;
(v) Renal insufficiency, as defined by a glomerular filtration rate < 30 ml/min
(vi) Scheduled for anesthesia without the use of muscle relaxants.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7837 |
| Ander register | METC LUMC : P17.050 |