BX1000
DrugIV BX1000
NCT Number: NCT05687253
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Research Center, San Antonio, Texas, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV BX1000
IV Rocuronium
Time frame: Within 2 minutes after administration
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Incidence of Adverse Events Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Changes in Blood Pressure Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Changes in Heart Rate Following Administration of Neuromuscular Blocking agent
Time frame: Within 30 days after administration
Assessment of Changes in Vital signs Following Administration of Neuromuscular Blocking agent
Time frame: Within 1 day after administration
Measurement of Twitch Suppression via Electromyography Following Administration of Neuromuscular Blocking agent
Time frame: Within 1 day after administration
Measurement of Twitch Recovery via Electromyography Following Administration of Neuromuscular Blocking agent
Baudax Bio
Industry
A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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