No registrations found.
ID
Source
Brief title
Health condition
patients receiving neuromuscular blocking agents required for their clinical care during a surgical procedure
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to provide EMG 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 outcome
o Investigating the quality of the applied skin electrodes (clinically available 3M Red Dot electrodes)
o Observing the applicability of the prototype (easy of use, …)
Background summary
Incomplete recovery from neuromuscular blockade after anesthesia and surgery continues to be a common problem in the post-anesthesia care unit. There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting using neurostimulation
Study objective
There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting
Study design
During operation
Intervention
As this is an observational trial, no additional interventions will be done.
Inclusion 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
- Presence of an underlying neuromuscular disease
- Presence of renal or hepatic disease
- Subject has open skin sores at locations needed for electrode application
- Patient taking the following medication:
- anti-seizure medication
- anti-cholinestase medication
- magnesium sulfate
Design
Recruitment
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 | NL4626 |
| NTR-old | NTR4777 |
| Other | : 2014/218 |