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
1 other identifier
interventional
80
1 country
2
Brief Summary
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2022
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2022
CompletedFirst Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2023
CompletedAugust 1, 2023
July 1, 2023
6 months
December 9, 2022
July 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Intubation Conditions
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
Within 2 minutes after administration
Secondary Outcomes (6)
Assessment of Safety And Tolerability - Adverse Events
Within 30 days after administration
Assessment of Safety And Tolerability - Blood Pressure
Within 30 days after administration
Assessment of Safety And Tolerability - Heart Rate
Within 30 days after administration
Assessment of Safety And Tolerability - Blood Oxygen Saturation
Within 30 days after administration
Assessment of Onset of Neuromuscular Blockade
Within 1 day after administration
- +1 more secondary outcomes
Study Arms (4)
BX1000 0.15 mg/kg
EXPERIMENTALBX1000 0.15 mg/kg IV Bolus
BX1000 0.25 mg/kg
EXPERIMENTALBX1000 0.25 mg/kg IV Bolus
BX1000 0.35 mg/kg
EXPERIMENTALBX1000 0.35 mg/kg IV Bolus
Rocuronium 0.6 mg/kg
ACTIVE COMPARATORRocuronium bromide 0.6 mg/kg IV Bolus
Interventions
Eligibility Criteria
You may qualify if:
- Providing informed consent
- Undergoing elective surgery utilizing IV general anesthesia
- Normal airway assessment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baudax Biolead
Study Sites (2)
Research Center
San Antonio, Texas, 78240, United States
Research Center
Salt Lake City, Utah, 84107, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind, active controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
January 18, 2023
Study Start
October 25, 2022
Primary Completion
April 10, 2023
Study Completion
May 8, 2023
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share