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Clinical trial

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

ID
Name
BDX-22-006
Description
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
Trial arms
Trial start
2022-10-25
Estimated PCD
2023-04-10
Trial end
2023-05-08
Status
Completed
Phase
Early phase I
Treatment
BX1000
IV BX1000
Arms:
BX1000 0.15 mg/kg, BX1000 0.25 mg/kg, BX1000 0.35 mg/kg
Rocuronium Bromide
IV Rocuronium
Arms:
Rocuronium 0.6 mg/kg
Size
80
Primary endpoint
Assessment of Intubation Conditions
Within 2 minutes after administration
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blind, active controlled', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2023-08-01

1 organization

2 products

3 indications

Organization
Baudax Bio
Product
BX1000
Indication
Neuromuscular Blockade
Indication
Anesthesia
Indication
Surgery
Product
Rocuronium Bromide