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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BX1000 0.15 mg/kg | Experimental | BX1000 0.15 mg/kg IV Bolus |
|
| BX1000 0.25 mg/kg | Experimental | BX1000 0.25 mg/kg IV Bolus |
|
| BX1000 0.35 mg/kg | Experimental | BX1000 0.35 mg/kg IV Bolus |
|
| Rocuronium 0.6 mg/kg | Active Comparator | Rocuronium bromide 0.6 mg/kg IV Bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BX1000 | Drug | IV BX1000 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Intubation Conditions | Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent | Within 2 minutes after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety And Tolerability - Adverse Events | Assessment of Incidence of Adverse Events Following Administration of Neuromuscular Blocking agent | Within 30 days after administration |
| Assessment of Safety And Tolerability - Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | San Antonio | Texas | 78240 | United States | ||
| Research Center |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Double-blind, active controlled
| Rocuronium Bromide | Drug | IV Rocuronium |
|
Assessment of Changes in Blood Pressure Following Administration of Neuromuscular Blocking agent
| Within 30 days after administration |
| Assessment of Safety And Tolerability - Heart Rate | Assessment of Changes in Heart Rate Following Administration of Neuromuscular Blocking agent | 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 | Within 30 days after administration |
| Assessment of Onset of Neuromuscular Blockade | Measurement of Twitch Suppression via Electromyography Following Administration of Neuromuscular Blocking agent | Within 1 day after administration |
| Assessment of Neuromuscular Recovery | Measurement of Twitch Recovery via Electromyography Following Administration of Neuromuscular Blocking agent | Within 1 day after administration |
| Salt Lake City |
| Utah |
| 84107 |
| United States |
| D011083 |
| Polycyclic Compounds |