A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 14
- 主要终点
- Number of Participants With a Successful Procedure
研究概览
简要总结
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).
- •American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through
- •Body mass index (BMI) ≤
- •Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
- •For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).
- •Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.
- •Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.
排除标准
- •Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
- •Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
- •Patients on mechanical ventilation.
- •Tracheal stenosis.
- •Planned laser bronchoscopy, rigid scope bronchoscopy.
- •Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.
- •Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
- •Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
- •Patient with a history of drug or ethanol abuse within the past two years.
- •Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.
- •Participation in any previous clinical study with remimazolam.
- •Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).
研究组 & 干预措施
Remimazolam
Double-blind Remimazolam arm: 5 mg iv for sedation induction, and 2.5 mg iv top-ups for sedation maintenance.
Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses
干预措施: Remimazolam (Drug)
Placebo
Double-blind placebo arm as inactive control
Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses
干预措施: Placebo (Drug)
Midazolam
Open-label Midazolam arm: 1.75 mg* iv for sedation induction and 1.0 mg* iv for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.
Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses
干预措施: Midazolam (Drug)
结局指标
主要结局
Number of Participants With a Successful Procedure
时间窗: From first dose of study drug to removal of bronchoscope (average time not known)
Success of Procedure measured by completion of bronchoscopy, no requirement for an alternative rescue sedative medication and no requirement for more than 5 doses of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the open-label midazolam arm.
次要结局
- Time to Fully Alert(From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert)
- Time to Ready for Discharge(After the last dose of study drug AND after the end of the bronchoscopy, until discharge)
- Time to Start of Procedure(From first dose of study drug until insertion of the bronchoscope)