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

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

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia; Neuromuscular Blockade
• Intervention / Treatment: Drug: BX1000; Drug: Rocuronium Bromide

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78240
      • Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BX1000 0.15 mg/kg; BX1000 0.15 mg/kg IV Bolus	Drug: BX1000; IV BX1000
Experimental: BX1000 0.25 mg/kg; BX1000 0.25 mg/kg IV Bolus	Drug: BX1000; IV BX1000
Experimental: BX1000 0.35 mg/kg; BX1000 0.35 mg/kg IV Bolus	Drug: BX1000; IV BX1000
Active Comparator: Rocuronium 0.6 mg/kg; Rocuronium bromide 0.6 mg/kg IV Bolus	Drug: Rocuronium Bromide; IV Rocuronium

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baudax Bio

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anticonvulsants; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Bromides; Rocuronium
• Other Study ID Numbers: BDX-22-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No