NCT05557253招募中不适用
Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Intraoperative hypotension
研究概览
简要总结
This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo elective extracranial-intracranial bypass surgery
- •American Society of Anesthesiologists grade 1,2,3
- •Age > 18 years old
排除标准
- •Refuse to participate to the study
- •American Society of Anesthesiologists grade 4
- •Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- •Allergic history of benzodiazepine
- •Acute narrow-angle glaucoma
- •Shock or Coma
- •Acute alcohol addicted
- •Obstructive sleep apnea
- •dependency on alcohol or drug
- •Severe acute respiratory insufficiency
- •Hypersensitivity to Dextran 40
研究组 & 干预措施
remimazolam group
Experimental
General anesthesia is induced and maintained with remimazolam.
干预措施: Remimazolam (Drug)
balanced group
Active Comparator
General anesthesia is induced with propofol and maintained with desflurane.
干预措施: Balanced Anesthesia (Drug)
结局指标
主要结局
Intraoperative hypotension
时间窗: During surgery
Target Systolic Blood Pressure \< 80%
次要结局
- Inotropic requirements(During surgery)
- Incidence of bradycardia(During surgery)
- Incidence of tachycardia(During surgery)
- Maximum systolic blood pressure(During surgery)
- Minimum systolic blood pressure(During surgery)
- Brain relaxation score(Immediately after dura opening)
研究者
Chang-Hoon Koo
Assistant professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Remimazolam and Postoperative Nausea and Vomiting in High-risk PatientsPostoperative Nausea and VomitingBenzodiazepineHigh-risk PatientsNCT04861337Peking University First Hospital552
尚未招募
Unknown
Effects of Remimazolam on Intraoperative Blood Pressure Control in Interventional Cerebral Aneurysm Coil EmbolizatioDiseases of the circulatory systemKCT0008343Korea University Anam Hospital30
尚未招募
Unknown
Evaluation of the Effect of Remimazolam on Intraoperative Motor Evoked Potential Monitoring - Comparison with PropofolJPRN-UMIN000049191niversity of Occupational and Environmental Health, Japan60
招募中
不适用
Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With MidazolamSedation and AnalgesiaNCT05160987Zhujiang Hospital440
已完成
不适用
Effect of Remimazolam on Postoperative Nausea and VomitingPostoperative Nausea and VomitingNCT05439057Inje University108