algehele anesthesie met spierverslappers anesthetized and neuromuscular blockade
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age 18 years or older; - Subject meets the American Society of Anesthesiology (ASA) physical status I-III criteria (Table I); - Subject has provided written informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - - Presence of an underlying neuromuscular disease - Presence of renal or hepatic disease - Subject has open skin sores at locations needed for electrode application - Patient is taking the following medication: - anti-seizure medication - anti-cholinestase medication - magnesium sulfate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to provide safety and performance data of the TetraGraph device on anesthetized subjects. Performance will be assessed post hoc by analyzing objective EMG data and correlating with the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Investigating the quality of the applied skin electrodes (clinically available 3M Red Dot electrodes) - Observing the applicability of the prototype (easy of use, *) | — |
Countries
Netherlands