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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687253
• Other study ID #: BDX-22-006
• Status: Completed
• Phase: Phase 2
• Start date: October 25, 2022
• Est. completion date: May 8, 2023

Study information

• Verified date: July 2023
• Source: Baudax Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 8, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Neuromuscular Blockade
• Surgery

Intervention

Drug:
• BX1000
IV BX1000
• Rocuronium Bromide
IV Rocuronium

Locations

Country	Name	City	State
United States	Research Center	Salt Lake City	Utah
United States	Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baudax Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Intubation Conditions	Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent	Within 2 minutes after administration
Secondary	Assessment of Safety And Tolerability - Adverse Events	Assessment of Incidence of Adverse Events Following Administration of Neuromuscular Blocking agent	Within 30 days after administration
Secondary	Assessment of Safety And Tolerability - Blood Pressure	Assessment of Changes in Blood Pressure Following Administration of Neuromuscular Blocking agent	Within 30 days after administration
Secondary	Assessment of Safety And Tolerability - Heart Rate	Assessment of Changes in Heart Rate Following Administration of Neuromuscular Blocking agent	Within 30 days after administration
Secondary	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
Secondary	Assessment of Onset of Neuromuscular Blockade	Measurement of Twitch Suppression via Electromyography Following Administration of Neuromuscular Blocking agent	Within 1 day after administration
Secondary	Assessment of Neuromuscular Recovery	Measurement of Twitch Recovery via Electromyography Following Administration of Neuromuscular Blocking agent	Within 1 day after administration