NCT05687253

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Baudax Bio · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neuromuscular Blockade
• Anesthesia
• Surgery

Interventions

Type	Name	Description
DRUG	BX1000	IV BX1000
DRUG	Rocuronium Bromide	IV Rocuronium

Timeline

• Start date: 2022-10-25
• Primary completion: 2023-04-10
• Completion: 2023-05-08
• First posted: 2023-01-18
• Last updated: 2023-08-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study