TetraGraph to Evaluate Onset and Recovery Times of Rocuronium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TetraGraph.
- Who it may be relevant to
- Registry conditions: Surgery, Neuromuscular Blockade. Basic parameters: from 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium
Overview
In most clinical instances, direct laryngoscopy and endotracheal intubation is performed after a set time (generally 60 seconds) following the administration of a neuromuscular (NM) blocking agent, rocuronium. Although the average onset time is 60 seconds, clinical studies show a standard deviation around the mean onset time of 10-20 seconds, meaning that a significant number of patients do not achieve complete NM blockade by 60 seconds. Given the above noted variability, complete NM blockade may not be achieved in 60 seconds in a significant percentage of patients, resulting in more problematic direct laryngoscopy and endotracheal intubation. Various studies have shown a higher incidence of perioperative respiratory events and postoperative concerns (sore throat, vocal cord injury) when NM blockade is not complete prior to endotracheal intubation. This study aims to use the TetraGraph monitor to clearly identify onset times of rocuronium. Additionally, whenever feasible based on the clinical needs of the case, recovery times after the single dose of rocuronium will be recorded.
Interventions
- Device TetraGraph
A monitor that provides an electrical stimulation of the peripheral nerve and directly measures the amplitude of the evoked response of the muscles, thereby providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG).
Primary outcome measures
- Onset time [Time frame: Baseline]
Secondary outcome measures (1)
- Recovery time [Time frame: At the completion of surgery]
Eligibility criteria
Inclusion criteria
- consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients
- undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium
Exclusion criteria
- Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
- Patients undergoing a surgical procedure in which neuromuscular blockade is not required
- Edematous patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07435792 · STUDY00005738