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临床试验/NCT03573999
NCT03573999已完成4 期

Effect of Isosmotic Doses of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation in Supratentorial Craniotomies

Aristotle University Of Thessaloniki2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年6月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
54
试验地点
2
主要终点
Changes of jugular venous oxygen saturation

研究概览

简要总结

Usage of osmotic agents is a standard practice in neuroanesthesia since cerebral edema is a very common situation for patients with pathology in the brain. Cerebral edema is defined as the accumulation of fluid in the intracellular or extracellular compartments of the brain. Among other situations that have nothing to do with the brain, a supratentorial pathology such as a tumor, traumatic injury or an aneurysm, will lead to disruption of blood-brain barrier, and energy crisis of the cells that will cause mainly vasogenic and cytotoxic cerebral edema. The most common monitoring method for "measuring" cerebral edema is ICP (intracranial pressure) in which normal values are (with differences in the bibliography) 10-15 mmHg.

The osmotic agents used most in neuroanesthesia are mannitol 20% and hypertonic NaCl 7.5% or 3%. Their brain relaxation effectiveness is supposed to be quite the same between the two different agents. Their main difference is that mannitol induces diuresis. Also, electrolyte disorders are another possibility after mannitol infusion. On the other hand, NaCl 7.5% causes vasodilation, does not induce diuresis and hemodynamically, even though it reduces SBP, it raises CO because of its excessive vasodilation. But both reduce cerebral edema due to the change of osmotic pressure in the vessels, that leads to extracting water from brain cells.

A supratentorial craniotomy is de facto worsening the oxygenation and metabolism condition of the surgical site, adding to the problem the intracranial pathology causes in the first place. So if oxygen provided is low and the metabolic rate is high, the rate of anaerobic metabolism will raise. Measuring the oxygen in the jugular bulb is the most reliable monitoring method of cerebral oxygenation and metabolism.

It becomes evident that optimization of cerebral oxygenation during a craniotomy will possibly affect the outcome of a patient, by improving it. So, if any superiority of one osmotic agent over the other could be demonstrated this will be very helpful in the decision making in routine clinical practice.

详细描述

Each participant will receive standard monitoring (ECG, SpO2, SBP, BIS, urine output, temperature). More detailed hemodynamic monitoring will be obtained by Edwards Lifesciences ClearSight system (CO, CI, SV, SVI, SVV, SVR, SVRI).

TCI Propofol and Remifentanil will be the agents of choice for induction and maintenance in anesthesia and cisatracurium will be used for neuromuscular blockade for intubation.

Protective mechanical ventilation will be chosen (7ml/kg IBW) with a Respiratory rate to obtain a PaCO2 of 35-40 mmHg. PEEP will be changed for the best PaO2/FiO2 ratio and FiO2 of choice will be 0.5.

The radial artery catheterization will be applied for direct blood pressure measurement and arterial blood gas sampling ( pH, PaO2, PaCO2, HCO3, BE, Osmolality, Lactic acid, Hb, Glucose, Na, K will be measured).

The jugular bulb ipsilateral to the craniotomy site will be catheterized for receiving blood samples for blood gas analysis. The following oxygenation and metabolic parameters / derivates will be measured or calculated: SjvO2, pH, PjvO2, PjvCO2, HCO3, BE, Osmolality, Lactic acid jv, Hb, Glucose, Na, K, AjvDO2, AjvCO2, O2ERbr, eRQbr, AjvDL, and LOI.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged between 18 and 75 years
  • ASA Physical status 1 to 3
  • Elective or semi-elective supratentorial craniotomy
  • Signed informed consent

排除标准

  • Craniotomy for suprasellar pathologies
  • Re-craniotomy at the same site
  • Perioperative sodium disorders (Na <130 mEq/L or >150 mEq/L)
  • Administration of intravenous mannitol or hypertonic saline 7.5% 24 hours or less before the surgery
  • Preoperative obstructive hydrocephalus
  • Congestive heart failure
  • Renal failure

研究组 & 干预措施

Mannitol 20%

Active Comparator

Mannitol 20% (4.6ml/kg) will be administered 20 minutes before dura matter opening.

干预措施: Mannitol (Drug)

Hypertonic saline 7.5%

Experimental

Hypertonic saline 7.5% (2ml/kg) will be administered 20 minutes before dura matter opening

干预措施: NaCl 7.5% (Drug)

结局指标

主要结局

Changes of jugular venous oxygen saturation

时间窗: 15 minutes after the end of the infusion of the tested osmotic agent

Alterations in jugular venous oxygen saturation (%) after intravenous infusion of isosmotic doses of mannitol 20% and hypertonic saline 7.5%

次要结局

  • Brain tension after intravenous infusion of isosmotic doses of mannitol 20% and hypertonic saline 7.5% assessed by Brain relaxation Score and subdural pressure(2 minutes before dura opening)
  • Changes of S-100b protein(6 hours after the end of the infusion of the tested osmotic agent)
  • Changes in the cardiac index(15 minutes after the end of the infusion of the tested osmotic agent)
  • Functional outcome of participants(7 days post surgery)

研究者

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

Georgia Tsaousi

Assistant Professor

Aristotle University Of Thessaloniki

研究点 (2)

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