跳至主要内容
临床试验/NCT07303985
NCT07303985已完成3 期

The Effects of Remimazolam on Cerebral Blood Flow Following General Anesthesia Induction

Jun Zhang1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年12月29日最近更新:
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Peak systolic blood flow velocity (PS)

研究概览

简要总结

This study will enroll 40 subjects aged 18 years or older scheduled for elective surgery under general anesthesia with endotracheal intubation. Basic medical history information will be collected. Subjects will be divided into two groups of 20 each: a remimazolam group and a propofol group. The study period will span from one day before surgery to one day after surgery. The study will assess middle cerebral artery cerebral blood flow following general anesthesia induction and postoperative anesthesia recovery.

详细描述

A significant reduction in cerebral blood flow (CBF) frequently occurs following general anesthesia induction. This decrease in CBF can lead to a reduction in the delivery of oxygen and glucose to brain tissue. If the magnitude or duration of this reduction exceeds the compensatory capacity of cerebral autoregulation, it can result in an imbalance between cerebral oxygen supply and demand, thereby increasing the risk of cerebral ischemia and neurological injury. Patients who are elderly, have hypertension, a history of cerebrovascular disease (e.g., stroke, intracranial arterial stenosis), or pre-existing brain injury are at higher risk for pronounced CBF reduction after induction, making them more susceptible to postoperative cognitive dysfunction, exacerbation of existing deficits, or new ischemic events. This underscores the urgent need to identify effective and safe therapeutic strategies to mitigate this risk.

Remimazolam is a novel benzodiazepine agent, structurally derived from midazolam with the introduction of a metabolically labile methyl propionate side chain. It similarly acts on the GABAA receptor, promoting chloride ion influx and inhibiting neuronal electrical activity. Administered intravenously for sedation and hypnosis, it is characterized by rapid onset, short duration of action, rapid recovery, minimal accumulation, and metabolism independent of hepatic or renal pathways. Previous studies indicate that benzodiazepines generally lack significant cardiovascular depressant effects and are associated with a lower incidence of hemodynamic instability during anesthesia induction. However, the specific impact of remimazolam on CBF following general anesthesia induction remains unclear.

Therefore, to further elucidate the effects of this novel benzodiazepine, remimazolam-which reportedly lacks significant cardiovascular depression-on CBF post-induction, we propose the following strategies for our clinical study: (1) compare remimazolam with the commonly used agent propofol for anesthesia induction; (2) administer remimazolam as an intravenous bolus of 0.3 mg/kg and propofol at 2 mg/kg for induction; (3) implement goal-directed fluid management during the peri-induction period; (4) utilize ultrasound to monitor blood flow in the middle cerebral artery; and (5) assess postoperative recovery parameters. Through this comprehensive approach, we aim to determine whether remimazolam offers a protective or optimizing effect on CBF during general anesthesia induction, thereby providing an empirical foundation for its routine clinical use in this context.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have signed the informed consent form and are willing to comply with the study protoco
  • Age greater than 18 years
  • ASA physical status classification I to II
  • Scheduled for elective surgery
  • Undergoing general anesthesia with endotracheal intubation
  • No history of cerebrovascular disease, carotid artery stenosis, or traumatic brain injury.

排除标准

  • History of intracranial lesions, carotid artery stenosis, or traumatic brain injury
  • Allergy or contraindications to remimazolam or propofol.

研究组 & 干预措施

Remimazolam

Experimental

Remimazolam is used as the sedative agent during the anesthesia induction period.

干预措施: Remimazolam (Drug)

Propofol

Other

Propofol is used as the sedative agent during the anesthesia induction period.

干预措施: Propofol (Group P) (Drug)

结局指标

主要结局

Peak systolic blood flow velocity (PS)

时间窗: 1, 3, 5, and 10 minutes after endotracheal intubation.

Peak systolic blood flow velocity (PS) in the middle cerebral artery following general anesthesia induction (at 1, 3, 5, and 10 minutes after endotracheal intubation). Peak systolic blood flow velocity (PS) is the maximum speed of blood flow recorded during the systolic phase of the cardiac cycle, typically measured in centimeters per second (cm/s). Peak systolic blood flow velocity (PS) normal values are vessel-specific and age-dependent. In healthy adults, the commonly cited reference range for the middle cerebral artery (MCA) is approximately 80-120 cm/s. This value decreases with age. For other intracranial arteries, PS is generally lower (e.g., 40-80 cm/s for vertebrobasilar arteries). Physiological factors like hematocrit and gender also cause minor variations. Clinically, PS values above 140-200 cm/s in the MCA often indicate significant pathology such as vasospasm or stenosis.

Peak systolic blood flow velocity (PS)

时间窗: 1, 3, 5, and 10 minutes after endotracheal intubation.

Peak systolic blood flow velocity (PS) in the middle cerebral artery following general anesthesia induction (at 1, 3, 5, and 10 minutes after endotracheal intubation). Peak systolic blood flow velocity (PS) is the maximum speed of blood flow recorded during the systolic phase of the cardiac cycle, typically measured in centimeters per second (cm/s). Peak systolic blood flow velocity (PS) normal values are vessel-specific and age-dependent. In healthy adults, the commonly cited reference range for the middle cerebral artery (MCA) is approximately 80-120 cm/s. This value decreases with age. For other intracranial arteries, PS is generally lower (e.g., 40-80 cm/s for vertebrobasilar arteries). Physiological factors like hematocrit and gender also cause minor variations. Clinically, PS values above 140-200 cm/s in the MCA often indicate significant pathology such as vasospasm or stenosis.

次要结局

  • The resistance index (RI) of the middle cerebral artery(1, 3, 5, and 10 minutes after endotracheal intubation)
  • Mean blood flow velocity (MV)(1, 3, 5, and 10 minutes after endotracheal intubation)
  • Postoperative recovery time(During the post-anesthesia care unit (PACU))
  • Postoperative cognitive score(On the first postoperative day.)
  • The resistance index (RI) of the middle cerebral artery(1, 3, 5, and 10 minutes after endotracheal intubation)
  • Mean blood flow velocity (MV)(1, 3, 5, and 10 minutes after endotracheal intubation)
  • Pulsatility index (PI)(1, 3, 5, and 10 minutes after endotracheal intubation)
  • Postoperative recovery time(During the post-anesthesia care unit (PACU))
  • Postoperative cognitive score(On the first postoperative day.)

研究者

发起方
Jun Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jun Zhang

Professor

Fudan University

研究点 (1)

Loading locations...

相似试验