Investigation of neuromuscular function and potential changes in muscle, nerve, and skin associated with intraoperative neuromuscular monitoring under general anesthesia in patients undergoing elective surgery.
Conditions
Interventions
Group 1: Arm 1: Single-arm prospective observational study with intraindividual comparison
Adult patients undergoing elective surgery under general anesthesia with neuromuscular blockade will be incl
Sponsors
Katholisches Klinikum Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Elective surgery under general anesthesia (duration 4-10 hrs) Use of a non-depolarizing neuromuscular blocking agent (rocuronium) as part of anesthesia management
Exclusion criteria
Exclusion criteria: • Neuromuscular disorders • Known peripheral neuropathies • Finger contractures • Skin diseases affecting the electrode area • Indication for ileus induction • Implanted electrical systems (e.g., active neurostimulator) • Allergy to rocuronium • Pregnancy • Patient refusal to participate in the study • Concurrent participation in another study • Limited capacity to provide informed consent, including care needs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraindividual difference in the relative change of CMAP amplitude in the ulnar nerve territory between baseline (after induction of anesthesia and prior to administration of the neuromuscular blocking agent) and the measurement after full neuromuscular recovery (TOF ratio = 100%) immediately before extubation, comparing the repeatedly stimulated and the non-stimulated extremity. A difference of = 20% is considered potentially clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin: Incidence, severity, and course of local skin changes (e.g., erythema, irritation, pressure marks, lesions) at electrode sites up to postoperative day 7 (extended follow-up if necessary). Sensory function: Changes in sensory perception (touch and pain) in the ulnar nerve territory compared to baseline, as well as occurrence of paresthesia or dysesthesia. Pain and discomfort: Intensity and course of local pain or abnormal sensations at the measurement sites, assessed using numerical rating scales (e.g., NRS/VAS) up to day 7. Motor function: Changes in hand motor function or muscle strength compared to baseline, including occurrence of clinically relevant functional impairment. Time course: Development of clinical parameters between postoperative day 0 and day 7, including proportion of transient versus persistent findings. Exploratory: Association between cumulative stimulation exposure (e.g., number of stimuli, TOF/PTC sequences) and changes in CMAP amplitude and clinical parameters. | — |
Countries
Germany
Contacts
Public ContactJennifer Herzog-Niescery
Katholisches Klinikum Bochum, St. Josef Hospital
Outcome results
None listed