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

Surgery Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anesthesia
• Neuromuscular Blockade
• Surgery

• NCT number: NCT05687253
• Study type: Interventional
• Source: Baudax Bio
• Status: Completed
• Phase: Phase 2
• Start date: October 25, 2022
• Completion date: May 8, 2023