The Clinical Impact of Magnesium Sulfate Administration before the Cerebral Aneurysm Clipping Surgery: A Prospective Multicenter Randomized Blinded Study
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009216
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 398
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)
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The clinical correlation of serum hypomagnesemia and post-operative CA clipping surgery pain scale using numeric rating scale (NRS or CNPS)
- Secondary Outcome Measures
Name Time Method The incidence of serum hypomagnesemia in post-operative cerebral aneurysm clipping surgery ;The incidence of serum hypomagnesemia related clinical symptoms (nausea, vomiting, tremor, tetany, muscle fasciculation) ;Number of opioid administrations for the pain control ;Post-operative delirium incidence (RASS) ;Post-operative ileus incidence ;The length of hospital and ICU stay (days);Metabolic intolerance (hyper/hypo glycemia, hyper/hypo natremia, hyper/hypo kalemia)