None listed
Conditions
Interventions
Drug : All patients undergoing craniotomy for cerebral aneurysm surgery will undergo serum magnesium level assessments on the day preceding surgery, as well as on post-operative days (POD) 0, 1, and 3
1 ampoule = 2g/20mL, Dai Han Pharm, Co. LTD., Korea) in the magnesium group or 0.9% saline solution in the control group, administered one day prior to the scheduled surgery. The randomization process
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 1 Pre-operative serum magnesium level below or above the normal range (1.8 – 3mg/dL) 2 History (within 6 months) or currently taking oral magnesium supplementation 3 Concurrent 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.) 4 At high nutritional risk (Nutritional Risk Screening 2002 version = 5) 5 Current or history of long term total enteral or parenteral nutrition (TPN) use 6 Unstable vital signs requiring the use of vasoactive agents 7 Concomitant medical illness that may interfere with the study outcome assessments (can cause hypomagnesemia) 7.1 Renal: alcoholism, diabetes, ketoacidosis, tubular defects (renal tubular acidosis, Welt syndrome, Gitelman syndrome and etc.), hyperthyroidism, hypoparathyroidism, hyperaldosteronism, hypercalcemia, hypophosphatemia 7.2 Gastro-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 7.3 Shifts from extracellular to intracellular fluids: blood transfusion (massive), epinephrine, acidosis, hungry bone syndrome, acute pancreatitis 7.4 Transdermal loss: excessive sweating, massive burns 7.5 The current electrolyte imbalances: hypokalemia, hypercalcemia, etc. 7.6 Systemic malignant tumor (brain, lung, gastric, colon, liver, breast and etc.) 7.7 Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative) 8 Taking 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) 9 Administrating magnesium content fluid (e.g., plasm-lyte, plasma solution and etc.) 10 Neuromuscular disease like myasthenia gravis 11 History of gastric or bowel surgery 12 Arrhythmia (AV block, sinus bradycardia and etc.) 13 Allergic to magnesium sulfate 14 Pregnancy 15 GCS < 6; brain death or imminent death (within 72 hours) 16 DNR (do not resuscitate) ordered patient 17 Currently participating in other investigational trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical correlation of serum hypomagnesemia and post-operative CA clipping surgery pain scale using numeric rating scale (NRS or CNPS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Korea, Republic of
Contacts
Public ContactMoinay Kim
Asan Medical Center
Outcome results
None listed