Comparison of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Endovascular Procedures of Cerebrovascular Disorders: A Single-center,Randomized,Single-blind, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- time to open eye
研究概览
简要总结
Remimazolam, a novel ultra-short acting benzodiazepine that combined the advantages of midazolam and remifentanil, has been developed for procedural sedation, induction and maintenance of general anesthesia, and sedation in the ICU. Previous studies have suggested that efficacy and safety of remimazolam are not inferior to propofol or midazolam in patients undergoing colonoscopy,bronchoscopy and some other treatments. However, the efficacy and potential adverse effects of remimazolam on patients undergoing endovascular procedures of cerebrovascular disorders is still unclear. In this study, we tend to conduct a single-center, randomized, single-blind ,non-inferiority trial to compare the efficacy and safety of remimazolam and propofol in endovascular procedures of cerebrovascular disorders.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization is done by an investigator who is not involved in anesthesia and outcome assessment. Participants are unaware of the group allocation. Due to the different color of remimazolam and propofol, the care provider is not blinded to the group allocation. At the end of the surgery, anesthetics are removed before outcome assessment. And the outcome assessor is blinded to the grouping.
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
- •aged 18 years or older
- •scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia
排除标准
- •American Society of Anesthesiologists class Ⅲ or higher
- •Hunt-Hess class Ⅲ or higher
- •body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡
- •large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
- •posterior circulation infarction
- •recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
- •severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
- •be allergic or likely to be allergic to the study drugs
- •participate in other clinical researchers within 3 months
- •history of neurological or psychiatric diseases
- •existed or suspected abuse of drug or alcohol
- •use of sedative or analgesics before surgery
- •patients with difficulty in communication
研究组 & 干预措施
Remimazolam
In remimazolam group, a 0.1 mg/kg dose of intravenous remimazolam was administered for induction, and 0.3-0.7 mg/kg/h infusion for maintenance after intubation.
干预措施: remimazolam (Drug)
Propofol
In propofol group, a 2 mg/kg dose of intravenous propofol was administered for induction, and 4-12 mg/kg/h infusion for maintenance after intubation.
干预措施: propofol (Drug)
结局指标
主要结局
time to open eye
时间窗: from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes
次要结局
- time to loss of consciousness(from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes)
- time to orientation(from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes)
- The highest Richmond Agitation and Sedation Score during emergence(from end of the surgery to 30 minutes after extubation, approximately 50 minutes)
- the level of serum interleukin-6, tumor necrosis factor-α and S100β(at the end of the surgery)
- time to recovery of spontaneous breathing(from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes)
- the level of lactic acid of arterial blood(at the end of the surgery)
- Renkin's Score at 30 days and three months after surgery(30 days and three months after surgery)
- length of postoperative ICU stay and hospital stay(from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days)
- time to endotracheal tube extubation(from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes)
- the dosages of vasoactive drugs during surgery(from initial administration of trial drugs to end of surgery, at an average of 3 hours)
- Number of episodes of hypotension during surgery(from initial administration of trial drugs to end of surgery, at an average of 3 hours)
- Number of episodes of hypertension during surgery(from initial administration of trial drugs to end of surgery, at an average of 3 hours)
- Glasgow outcome Score at discharge(at discharge, approximately 3 days after surgery)
- the incidence of major complications during postoperative hospitalization(from the end of surgery to discharge, approximately 3 days)
- the incidence of delirium during emergence(from end of surgery to 30 minutes after extubation)
- the incidence of delirium within 3 days after surgery(from end of surgery to 3 days after surgery)
研究者
Zhihong LU
Professor
Air Force Military Medical University, China