Neuromuscular BlockadePhase 2NCT05687253
Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
A Phase 2 study testing BX1000 and Rocuronium Bromide in people with Neuromuscular Blockade and Anesthesia, run by Baudax Bio at 2 sites in United States.
Trial summary
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade, Anesthesia, Surgery
- What is being tested?
- BX1000 and Rocuronium Bromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2022to 8 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Providing informed consent
- Undergoing elective surgery utilizing IV general anesthesia
- Normal airway assessment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Center
Salt Lake City, Utah, 84107
Research Center
San Antonio, Texas, 78240
About this study
Official title: 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).
Read the 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.
- Conditions
- Neuromuscular Blockade, Anesthesia, Surgery
- Being tested
- BX1000, Rocuronium Bromide
- Keywords
- Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BX1000Drug
IV BX1000
Rocuronium BromideDrug
IV Rocuronium
| Study group | Role | What they receive |
|---|---|---|
| BX1000 0.15 mg/kg | Experimental | BX1000 0.15 mg/kg IV Bolus Receives: Drug: BX1000 |
| BX1000 0.25 mg/kg | Experimental | BX1000 0.25 mg/kg IV Bolus Receives: Drug: BX1000 |
| BX1000 0.35 mg/kg | Experimental | BX1000 0.35 mg/kg IV Bolus Receives: Drug: BX1000 |
| Rocuronium 0.6 mg/kg | Active comparator | Rocuronium bromide 0.6 mg/kg IV Bolus Receives: Drug: Rocuronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Intubation Conditions
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
Measured: Within 2 minutes after administration
Secondary outcomes (6)
Assessment of Safety And Tolerability - Adverse Events
Assessment of Incidence of Adverse Events Following Administration of Neuromuscular Blocking agent
Measured: Within 30 days after administration
Assessment of Safety And Tolerability - Blood Pressure
Assessment of Changes in Blood Pressure Following Administration of Neuromuscular Blocking agent
Measured: Within 30 days after administration
Assessment of Safety And Tolerability - Heart Rate
Assessment of Changes in Heart Rate Following Administration of Neuromuscular Blocking agent
Measured: 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
Measured: Within 30 days after administration
Assessment of Onset of Neuromuscular Blockade
Measurement of Twitch Suppression via Electromyography Following Administration of Neuromuscular Blocking agent
Measured: Within 1 day after administration
Assessment of Neuromuscular Recovery
Measurement of Twitch Recovery via Electromyography Following Administration of Neuromuscular Blocking agent
Measured: Within 1 day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start25 Oct 2022
- Primary completion10 Apr 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baudax Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687253
- Sponsor's protocol ID
- BDX-22-006
- Status last verified
- Jul 2023
- First submitted
- 9 Dec 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
- ClinicalTrials.gov ID
- NCT05687253
- Acronym / sponsor ID
- BDX-22-006
- Conditions
- Neuromuscular Blockade, Anesthesia, Surgery
- Keywords
- Intubation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baudax BioIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BX1000 0.15 mg/kg | Experimental | Drug: BX1000BX1000 0.15 mg/kg IV Bolus |
| BX1000 0.25 mg/kg | Experimental | Drug: BX1000BX1000 0.25 mg/kg IV Bolus |
| BX1000 0.35 mg/kg | Experimental | Drug: BX1000BX1000 0.35 mg/kg IV Bolus |
| Rocuronium 0.6 mg/kg | Active comparator | Drug: Rocuronium BromideRocuronium bromide 0.6 mg/kg IV Bolus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Providing informed consent
- Undergoing elective surgery utilizing IV general anesthesia
- Normal airway assessment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BX1000IV BX1000 | Drug | BX1000 0.15 mg/kg, BX1000 0.25 mg/kg, BX1000 0.35 mg/kg |
| Rocuronium BromideIV Rocuronium | Drug | Rocuronium 0.6 mg/kg |
Primary outcome
Assessment of Intubation Conditions
Time frame: Within 2 minutes after administration
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
6 secondary outcomes
Assessment of Safety And Tolerability - Adverse Events
Time frame: Within 30 days after administration
Assessment of Safety And Tolerability - Blood Pressure
Time frame: Within 30 days after administration
Assessment of Safety And Tolerability - Heart Rate
Time frame: Within 30 days after administration
Assessment of Safety And Tolerability - Blood Oxygen Saturation
Time frame: Within 30 days after administration
Assessment of Onset of Neuromuscular Blockade
Time frame: Within 1 day after administration
Assessment of Neuromuscular Recovery
Time frame: Within 1 day after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BX1000 and Rocuronium Bromide in people with Neuromuscular Blockade and Anesthesia, run by Baudax Bio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Intubation Conditions (time frame: Within 2 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.