KCT0009216尚未招募Unknown
The Clinical Impact of Magnesium Sulfate Administration before the Cerebral Aneurysm Clipping Surgery: A Prospective Multicenter Randomized Blinded Study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 398
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1.Age =19 years and = 75 years
- •2.Patient undergoing surgery (craniotomy) for either unruptured or ruptured (= subarachnoid hemorrhage, SAH) intracranial aneurysms and subsequently admitted to the ICU
- •3.Glasgow coma score (GCS): 9~ 15 (able to answer the post-operative pain scale questionnaire)
排除标准
- •1Pre-operative serum magnesium level below or above the normal range (1.8 – 3mg/dL)
- •2History (within 6 months) or currently taking oral magnesium supplementation
- •3Concurrent medical illnesses resulting in severe pain prior to surgery, for which the patient is receiving pain-relief medication (such as migraine, cluster headache, gout, fibromyalgia, spinal disease and etc.)
- •4At high nutritional risk (Nutritional Risk Screening 2002 version = 5)
- •5Current or history of long term total enteral or parenteral nutrition (TPN) use
- •6Unstable vital signs requiring the use of vasoactive agents
- •7Concomitant medical illness that may interfere with the study outcome assessments (can cause hypomagnesemia)
- •7.1Renal: alcoholism, diabetes, ketoacidosis, tubular defects (renal tubular acidosis, Welt syndrome, Gitelman syndrome and etc.), hyperthyroidism, hypoparathyroidism, hyperaldosteronism, hypercalcemia, hypophosphatemia
- •7.2Gastro-intestinal: diarrhea or vomiting, dietary deficiency (including protein – calorie malnutrition, parental and enteral feeding with inadequate magnesium), familial magnesium malabsorption, GI fistula, inflammatory bowel disease, refeeding syndrome, laxative abuse, magnesium malabsorption (chronic pancreatitis), nasogastric suction, surgical resection
- •7.3Shifts from extracellular to intracellular fluids: blood transfusion (massive), epinephrine, acidosis, hungry bone syndrome, acute pancreatitis
- •7.4Transdermal loss: excessive sweating, massive burns
- •7.5The current electrolyte imbalances: hypokalemia, hypercalcemia, etc.
- •7.6Systemic malignant tumor (brain, lung, gastric, colon, liver, breast and etc.)
- •7.7Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative)
- •8Taking medication that can cause hypomagnesemia
- •Diuretics: thiazide, loop, K-sparing diuretics and etc.
- •Antibiotics/antifungal: aminoglycoside, amphotericin B, gentamycin and etc.
- •Digoxin, cisplatin, tacrolimus, pentamidine, proton pump inhibitor (PPI)
- •9Administrating magnesium content fluid (e.g., plasm-lyte, plasma solution and etc.)
- •10Neuromuscular disease like myasthenia gravis
- •11History of gastric or bowel surgery
- •12Arrhythmia (AV block, sinus bradycardia and etc.)
- •13Allergic to magnesium sulfate
- •14Pregnancy
- •15GCS < 6; brain death or imminent death (within 72 hours)
- •16DNR (do not resuscitate) ordered patient
- •17Currently participating in other investigational trials
研究者
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