Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-05-08

Brief Summary

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

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Detailed Description

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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

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Neuromuscular Blockade Anesthesia Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind, active controlled

Study Groups

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BX1000 0.15 mg/kg

BX1000 0.15 mg/kg IV Bolus

Group Type EXPERIMENTAL

BX1000

Intervention Type DRUG

IV BX1000

BX1000 0.25 mg/kg

BX1000 0.25 mg/kg IV Bolus

Group Type EXPERIMENTAL

BX1000

Intervention Type DRUG

IV BX1000

BX1000 0.35 mg/kg

BX1000 0.35 mg/kg IV Bolus

Group Type EXPERIMENTAL

BX1000

Intervention Type DRUG

IV BX1000

Rocuronium 0.6 mg/kg

Rocuronium bromide 0.6 mg/kg IV Bolus

Group Type ACTIVE_COMPARATOR

Rocuronium Bromide

Intervention Type DRUG

IV Rocuronium

Interventions

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BX1000

IV BX1000

Intervention Type DRUG

Rocuronium Bromide

IV Rocuronium

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes