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ID
Source
Brief title
Health condition
N.A.
Sponsors and support
Intervention
Outcome measures
Primary outcome
TOF and TOF ratio values differences between both groups
Secondary outcome
Time to TOF Ratio 0.9
Background summary
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.
Study objective
The TOF cuff behaves similarly to EMG in terms of bias, limits of agreement and precision when comparing the TOF cuff to EMG.
Study design
N.A.
Intervention
N.A.
Inclusion criteria
(i) ASA class I-III
(ii) > 18 years of age;
(iii) Ability to give oral and written informed consent.
Exclusion criteria
(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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7837 |
| Other | METC LUMC : P17.050 |