Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam - A Parallel, Multicenter, Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.
详细描述
Investigational drug#remimazolam for injection Study title#Effect of Remimazolam with Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared with Midazolam - A parallel, Multicenter, Single-blind Randomized Controlled Trial Principal Investigator#Professor Zhanguo Liu, Dr.Jing Cai, Department of Critical Care Unit, Zhujiang Hospital, Southern Medical University Study subjects#Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h are enrolled in this study. The ages of patients should be in the range from 18 to 80.
Study phase# Investigator Initiated Trial(IIT) Study objectives#The objective of the study is to determine whether remimazolam, compared with midazolam, reduces duration of ventilation in severe patients.
Study design#A parallel, Multicenter, Single-blind Randomized Controlled Trial. Medication method#Remimazolam group#Patients are administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to Richmond Agitation Sedation Scale (RASS) scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved.
Midazolam group#Patients are administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to Richmond Agitation Sedation Scale (RASS) scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved.
Spontaneous breathing test (SBT) is conducted daily while patients are stable. Weaning would be considered after a successful SBT, and the sedation for study need to be stopped subsequently. If the weaning failed, mechanical ventilation and sedation would be used immediately according to sedation targets. Weaning success is defined as the ability to successfully complete the SBT and sustain spontaneous breathing for 48h after extubation.
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
- Single (Participant)
盲法说明
single-blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.
- •Age 18-80 years.
- •Voluntary informed consent.
排除标准
- •Surgical treatment is performed within 24 hours.
- •Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.
- •Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.
- •The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.
- •Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.
- •History of alcohol and drug abuse.
- •End stages of lung diseases, such as pulmonary fibrosis, lung damage, etc.
研究组 & 干预措施
Remimazolam Group
The patients are administered with sedation of remimazolam and analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drug before enrollment, patient would be administered with a bolus of remimazolam with 0.1-0.3mg/kg intravenously in 1 minute for the first time. And maintenance dose is 0.25-0.1mg/kg/h, meanwhile the dose of remimazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded.
干预措施: Remimazolam (Drug)
Midazolam Group
The patients are administered with sedation of midazolam analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drugs before enrollment, patients would be administered with a bolus of midazolam with 0.01-0.05mg/kg intravenously in 1 minute for the first time. And the maintenance dose is 0.02-0.1mg/kg/h, meanwhile the dose of midazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded.
干预措施: Midazolam (Drug)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
Weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time. The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.
次要结局
- Length of stay in ICU and total length of stay(From the date of admission in ICU until the date of transfer from ICU)
- Duration of endotracheal intubation(From the date of enrollment until the date of pulling out the endotracheal tube, assessed up to 28 days)
- Completion rate of sedation goal(From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days)
- Remediation is defined as requiring combination with other sedations(From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days)
- Anterograde amnesia(From the date of enrollment until the date of successful ventilator withdrawal)
- 28 day mortality(From the date of enrollment until the date of death from any cause, assessed up to 28 days)
研究者
Liu Zhanguo
Deputy chief physician of critical medicine department
Zhujiang Hospital