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OpenTrials
Completed

NCT Number: NCT05687253

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).

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Center, San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BX1000

Drug

IV BX1000

Rocuronium bromide

Drug

IV Rocuronium

Primary outcomes

  1. Assessment of Intubation Conditions

    Time frame: Within 2 minutes after administration

    Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent

Secondary outcomes

  1. Assessment of Safety And Tolerability - Adverse Events

    Time frame: Within 30 days after administration

    Assessment of Incidence of Adverse Events Following Administration of Neuromuscular Blocking agent

  2. Assessment of Safety And Tolerability - Blood Pressure

    Time frame: Within 30 days after administration

    Assessment of Changes in Blood Pressure Following Administration of Neuromuscular Blocking agent

  3. Assessment of Safety And Tolerability - Heart Rate

    Time frame: Within 30 days after administration

    Assessment of Changes in Heart Rate Following Administration of Neuromuscular Blocking agent

  4. Assessment of Safety And Tolerability - Blood Oxygen Saturation

    Time frame: Within 30 days after administration

    Assessment of Changes in Vital signs Following Administration of Neuromuscular Blocking agent

  5. Assessment of Onset of Neuromuscular Blockade

    Time frame: Within 1 day after administration

    Measurement of Twitch Suppression via Electromyography Following Administration of Neuromuscular Blocking agent

  6. Assessment of Neuromuscular Recovery

    Time frame: Within 1 day after administration

    Measurement of Twitch Recovery via Electromyography Following Administration of Neuromuscular Blocking agent

Sponsors and collaborators

Lead sponsor

Baudax Bio

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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