Surgery
Conditions
Brief summary
The primary aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.
Detailed description
This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.
Interventions
DEVICETetraGraph
The TetraGraph is a dedicated neuromuscular stimulator / recorder intended to evoke, record, and analyze muscle action potentials during surgical procedures
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 years or older. 2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I). 3. Subject has provided verbal consent 4. BMI \<39
Exclusion criteria
1. Presence of an underlying neuromuscular disease. 2. Presence of renal or hepatic disease. 3. Subject has open skin sores in the locations needed for electrode application (forearms). 4. Patients on oral anticholinesterase, anti-seizure medications, and magnesium sulfate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary performance assessment of TetraGraph device | Duration of surgery | Agreement between the mAP and mADM EMG based TOF ratios |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary performance assessment of TetraGraph device | Duration of surgery | Correlation between stimulation current and T1 twitch height in the two muscles |
Countries
United States
Outcome results
None listed