Clinical trial NCT05687253: Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
Official title: A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuromuscular Blockade
Anesthesia
Surgery
Keywords: Intubation
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Intubation Conditions
timeFrame: Within 2 minutes after administration
Secondary outcomes:
measure: Assessment of Safety And Tolerability - Adverse Events
timeFrame: Within 30 days after administration
measure: Assessment of Safety And Tolerability - Blood Pressure
timeFrame: Within 30 days after administration
measure: Assessment of Safety And Tolerability - Heart Rate
timeFrame: Within 30 days after administration
measure: Assessment of Safety And Tolerability - Blood Oxygen Saturation
timeFrame: Within 30 days after administration
measure: Assessment of Onset of Neuromuscular Blockade
timeFrame: Within 1 day after administration
measure: Assessment of Neuromuscular Recovery
timeFrame: Within 1 day after administration
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Research Center
state: Utah
Study officials:
References: