Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
Intubation conditions will be assessed in anesthetized subjects undergoing an elective surgical procedure utilizing general anesthesia. Following administration of IV anesthesia, subjects will have electromyography (EMG) neuromuscular monitoring device applied prior to administration of neuromuscular blocking agent (NMBA). NMBA will be administered and assessment of intubation conditions will begin 60 seconds after administration according to the methods defined in Viby-Mogensen 1996; assessment will be repeated at 90 and 120 seconds after administration when intubation has not already been completed. After intubation is completed, subjects will progress to have their elective surgery completed and will be maintained under general anesthesia until neuromuscular function is recovered. Once recovered from anesthesia and extubation, subjects will be monitored in a recovery area until they are suitable to be discharged to the inpatient floor, after which time they may be discharged at the clinical discretion of the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
IV BX1000
IV Rocuronium
Research Center
San Antonio, Texas, United States
Research Center
Salt Lake City, Utah, United States
Assessment of Intubation Conditions
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
Time frame: Within 2 minutes after administration
Assessment of Safety And Tolerability - Adverse Events
Assessment of Incidence of Adverse Events Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Safety And Tolerability - Blood Pressure
Assessment of Changes in Blood Pressure Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Safety And Tolerability - Heart Rate
Assessment of Changes in Heart Rate Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Safety And Tolerability - Blood Oxygen Saturation
Assessment of Changes in Vital signs Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Onset of Neuromuscular Blockade
Measurement of Twitch Suppression via Electromyography Following Administration of Neuromuscular Blocking agent
Time frame: Within 1 day after administration
Assessment of Neuromuscular Recovery
Measurement of Twitch Recovery via Electromyography Following Administration of Neuromuscular Blocking agent
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Time frame: Within 1 day after administration