A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Assessment of Intubation Conditions
Study Overview
Brief Summary
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind, active controlled
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Providing informed consent
- •Undergoing elective surgery utilizing IV general anesthesia
- •Normal airway assessment
Exclusion Criteria
- •Unstable disease or emergency surgical conditions
- •Known hypersensitivity to rocuronium, other NMB or study medications
- •History of anaphylaxis
- •History of neuromuscular junction disease
- •Personal or family history of malignant hyperthermia or pseudocholinesterase deficiency
- •Diagnosed or suspected sleep apnea
- •History of prior anesthetic complications
Arms & Interventions
BX1000 0.15 mg/kg
BX1000 0.15 mg/kg IV Bolus
Intervention: BX1000 (Drug)
BX1000 0.25 mg/kg
BX1000 0.25 mg/kg IV Bolus
Intervention: BX1000 (Drug)
BX1000 0.35 mg/kg
BX1000 0.35 mg/kg IV Bolus
Intervention: BX1000 (Drug)
Rocuronium 0.6 mg/kg
Rocuronium bromide 0.6 mg/kg IV Bolus
Intervention: Rocuronium Bromide (Drug)
Outcomes
Primary Outcomes
Assessment of Intubation Conditions
Time Frame: Within 2 minutes after administration
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
Secondary Outcomes
- Assessment of Safety And Tolerability - Adverse Events(Within 30 days after administration)
- Assessment of Safety And Tolerability - Blood Pressure(Within 30 days after administration)
- Assessment of Safety And Tolerability - Heart Rate(Within 30 days after administration)
- Assessment of Safety And Tolerability - Blood Oxygen Saturation(Within 30 days after administration)
- Assessment of Onset of Neuromuscular Blockade(Within 1 day after administration)
- Assessment of Neuromuscular Recovery(Within 1 day after administration)