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临床试验/NCT05610774
NCT05610774已完成不适用

Using Optic Nerve Sheath Diameter to Monitor Intracranial Tension in Pre-Eclamptic Parturient Receiving Magnesium Sulfate in Combination With Dexmedetomidine

Benha University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Optic nerve sheath diameter (ONSD) measurments following Drug administration

研究概览

简要总结

Dexmedetomidine was reported to effectively reduce cerebral metabolism and ICP by decreasing cerebrospinal fluid pressure in patients with cerebral tumors or head injuries that require craniotomy. However, it was also reported to exhibit no effect on ICP. the effect of MgSO4 associated with dexmedetomidine on ONSD in severely pre-eclamptic parturient has been understudied . Though this study aims to evaluate the effect of dexmedetomidine infusion on raised ICP in severely pre-eclamptic parturients using ocular ultrasonography to determine ONSD as a measure of ICP.

详细描述

Dexmedetomidine, a highly selective α-2-receptor agonist, is a first-line sedative medication in ICU and has been increasingly used for obstetric anesthesia. Dexmedetomidine, which provides light sedation, possesses analgesic, sympatholytic, anxiolytic properties and attenuates the stress response without significant respiratory depression. In addition, dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow. However, the effects of dexmedetomidine on ICP are controversial.

Clinical signs of raised ICP are not specific and often difficult to interpret, especially during pregnancy and pre-eclampsia. Though the use of invasive devices is considered a gold standard in the measurement of ICP, Ocular sonography is a promising bedside tool, which serves as a noninvasive, readily available, and cost-effective means for indirectly measuring ICP.

Bedside ultrasound can be used as a point-of-care tool for rapidly measuring the optic nerve sheath diameter (ONSD), which is a validated indirect means for measuring ICP. An increase in ICP reflects as a raised ONSD since the optic nerve is surrounded by Dural sheath and cerebrospinal fluid (CSF) containing subarachnoid space, which is distensible in the retrobulbar segment, particularly when CSF pressures rise.

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • aged18 to 40 years with
  • at least 36 weeks gestation
  • admitted with diagnosis of severe pre-eclampsia and scheduled to receive Magnesium Sulphate therapy before delivery

排除标准

  • Presence of ocular wound or Prior ocular surgery
  • emergency cases, and evidence of fetal compromise
  • HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet levels)
  • Chronic hypertension
  • Hyperthyroidism, and diabetes mellitus
  • Presence of pre-existing chronic lung and/or cardiac diseases
  • Presence of pre-existing chronic renal and/or hepatic diseases
  • Presence of any chronic diseases of central nervous system.
  • known allergies to the tested drug.

研究组 & 干预措施

Group (D)

Experimental

Patients will receive a loading dose of iv dexmedetomidine followed by a maintenance infusion.

干预措施: Dexmedetomidine (Drug)

Group (C)

Placebo Comparator

patients will receive saline loading and infusion

干预措施: Saline (Drug)

结局指标

主要结局

Optic nerve sheath diameter (ONSD) measurments following Drug administration

时间窗: Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative

次要结局

  • The incidence of raised ICP in severe pre-eclampsia(Baseline (before starting MgSO4 therapy), and during 24 hours postoperative.)
  • Heart Rate (HR)(Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours)
  • The duration of hospital stay(one month after delivery)
  • Sedation Score(every 2 hours after drug infusion, till 24 postoperative hours)
  • mean arterial pressure (MAP) changes.(Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samar Rafik Mohamed Amin

lecturer of anesthesia and surgical ICU

Benha University

研究点 (1)

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