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

Baudax Bio

Status and phase: Completed; Phase 2

Conditions: Surgery; Neuromuscular Blockade; Anesthesia

Treatments: Drug: BX1000; Drug: Rocuronium Bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05687253

BDX-22-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups

BX1000 0.15 mg/kg

Experimental group

Description:

BX1000 0.15 mg/kg IV Bolus

Treatment:

Drug: BX1000

BX1000 0.25 mg/kg

Experimental group

Description:

BX1000 0.25 mg/kg IV Bolus

Treatment:

Drug: BX1000

BX1000 0.35 mg/kg

Experimental group

Description:

BX1000 0.35 mg/kg IV Bolus

Treatment:

Drug: BX1000

Rocuronium 0.6 mg/kg

Active Comparator group

Description:

Rocuronium bromide 0.6 mg/kg IV Bolus

Treatment:

Drug: Rocuronium Bromide