Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery

Study Overview
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Brief Summary
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Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).

Detailed Description
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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.

Official Title
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A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery

Conditions
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Neuromuscular Blockade, Anesthesia, Surgery

Intervention / Treatment
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* Drug: BX1000
* Drug: Rocuronium Bromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BX1000 0.15 mg/kg<br>BX1000 0.15 mg/kg IV Bolus | Drug: BX1000<br>* IV BX1000<br>|
| Experimental: BX1000 0.25 mg/kg<br>BX1000 0.25 mg/kg IV Bolus | Drug: BX1000<br>* IV BX1000<br>|
| Experimental: BX1000 0.35 mg/kg<br>BX1000 0.35 mg/kg IV Bolus | Drug: BX1000<br>* IV BX1000<br>|
| Active Comparator: Rocuronium 0.6 mg/kg<br>Rocuronium bromide 0.6 mg/kg IV Bolus | Drug: Rocuronium Bromide<br>* IV Rocuronium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation