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临床试验/NCT04135456
NCT04135456进行中(未招募)1 期

Study on the Optimal Dosage of Mannitol in Aneurysmal Subarachnoid Hemorrhage Craniotomy

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2019年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
99
试验地点
1
主要终点
Brain relaxation score

研究概览

简要总结

Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients. However, the high ICP made it difficult to separate the subarachnoid space during the operation. Effective reduction of ICP was the key to the succession of the operation. But there is a lack of consensus on the management of raised ICP in aSAH. Mannitol is widely used to reduce ICP in patients with cerebral edema. The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality. The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function. However, the hypochloremic metabolic alkalosis, hypernatremia, hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown. The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects.

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute subarachnoid hemorrhage
  • Patients who underwent frontal-temporal craniotomy pterional approach aneurysm clipping surgery under general anesthesia.
  • Patients operated by the same surgeon (Dr. Chen Xiaolin).

排除标准

  • Patients who do not agree to the surgery.
  • Patients who have congestive heart failure and kidney insufficiency.
  • Patients who have pre-operative electrolyte imbalance.
  • Patients who did not take the frontotemporal pterygoid approach.
  • Patients with contraindications to mannitol due to low blood pressure.
  • Patients who have had more than 3 days from bleeding to surgery.
  • Patients with intracranial hematoma.
  • Patients with Hunt-Hess grades 4-
  • Patients who received intravenous mannitol within 6 hours before surgery.
  • Patients who underwent ventricle puncture and drainage surgery before surgery.

研究组 & 干预措施

Low dose group

Experimental

0.5g/kg of 20% mannitol administered at skin incision.

干预措施: Mannitol (Drug)

Medium dose group

Experimental

1.0g/kg of 20% mannitol administered at skin incision.

干预措施: Mannitol (Drug)

High dose group

Experimental

1.5g/kg of 20% mannitol administered at skin incision.

干预措施: Mannitol (Drug)

结局指标

主要结局

Brain relaxation score

时间窗: Intraoperative

The degree of brain relaxation after administration was assessed as four grades. denoting bulging or the condition that additional methods for brain relaxation are immediately and always required in order to continue the surgical procedure because of brain swelling; firm or the condition that additional methods for brain relaxation are occasionally required to continue the surgical procedure; adequate; perfectly relaxed. All patients received conventional frontotemporal pterional approach, and the time from skin incision to dural opening was constant for 30 minutes. At the time of dural opening, the degree of cerebral relaxation was evaluated, and the satisfactory cerebral relaxation was defined as 3 or 4 points.

次要结局

  • electrolyte change (sodium)(before the infusion of mannitol and 30 minutes after the administration of the study drug.)
  • electrolyte change (chlorine)(before the infusion of mannitol and 30 minutes after the administration of the study drug.)
  • electrolyte change (calcium)(before the infusion of mannitol and 30 minutes after the administration of the study drug.)
  • Subdural hematoma(CT scan 6 hours after surgery)
  • modified Rankin Score 3 months after surgery(3 months after surgery)
  • electrolyte change (potassium)(before the infusion of mannitol and 30 minutes after the administration of the study drug.)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Shuo

Director of Department of Cerebrovascular Neurosurgery

Beijing Tiantan Hospital

研究点 (1)

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