The aim of this study was to compare 1. early prognosis (mortality, morbidity) 2. changes in concentrations of serum syndecan-1,partial pressure of oxygen(on arterial blood gas analysis), perioperative transfusion, intraoperative vasopressor use between general anesthesia and nerve block in diabetic patients undergoing limb amputation surgery as a prospective randomized trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
General anesthesia is induced with propofol (0.5-2mg / kg), remifentanil (4-8㎍ / kg / hr) and rocuronium (0.4 \~ 0.6 mg / kg) involving laryngeal mask(supraglottic airway device) insertion or endotracheal intubation. Anesthesia is maintained with 1.0-2.5% sevoflurane and remifentanil.
ultrasound-guided popliteal sciatic nerve block is performed
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGearly prognosis (mortality)
death within 30days after surgery
Time frame: 30days after surgery
early prognosis (Unexpected return To The Operation Room)
Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit.
Time frame: 30days after surgery
early prognosis (Renal failure)
Indicate whether the patient had acute renal failure or worsening renal function resulting in ONE OR BOTH of the following: 1. Increase in serum creatinine level 3.0 x greater than baseline, or serum creatinine level \>=4 mg/dL. Acute rise must be at least 0.5 mg/dl 2. A new requirement for dialysis postoperatively.
Time frame: 30days after surgery
early prognosis (Pneumonia)
Indicate if the patient experienced pneumonia in the postoperative period. Pneumonia is defined as meeting three of five characteristics: fever, leucocytosis, CXR with infiltrate, positive culture from sputum, or treatment with antibiotics.
Time frame: 30days after surgery
early prognosis (Respiratory failure)
Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
Time frame: 30days after surgery
early prognosis (DVT Requiring Treatment)
Indicate whether the patient has experienced a deep venous thrombosis (DVT) confirmed by doppler study, contrast study, or other study that required treatment.
Time frame: 30days after surgery
early prognosis (Myocardial Infarct)
Indicate if the patient experienced a MI postoperatively as evidenced by: 1. Transmural infarction: Defined by the appearance of a new Q wave in two or more contiguous leads on ECG, or 2. Subendocardial infarction: (non-Q wave) Infarction, which is considered present in a patient having clinical, angiographic, electrocardiographic, and/or 3. Laboratory biomarker (CPK,Troponin) evidence of myocardial necrosis with an ECG showing no new Q waves
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Time frame: 30days after surgery
early prognosis (Surgical Site Infection)
Indicate the extent of surgical site infection if one was present within 30 days of surgery.
Time frame: 30days after surgery
early prognosis (New Central Neurological Event)
Indicate whether the patient experienced any of the following neurological events in the postoperative period that was not present preoperatively: 1. A central neurologic deficit persisting postoperatively for \> 72 hours. 2. A postoperatively transient neurologic deficit (TIA recovery within 24 hours; RIND recovery within 72 hours). 3. New postoperative coma that persists for at least 24 hours secondary to anoxic/ischemic and/or metabolic encephalopathy, thromboembolic event or cerebral bleed.
Time frame: 30days after surgery
early prognosis (Delirium)
Indicate whether the patient experienced delirium in the postoperative period marked by illusions, confusion, cerebral excitement, and having a comparatively short course.
Time frame: 30days after surgery
changes in concentrations of serum syndecan-1
Time frame: within 5 minutes before start of anesthesia(anesthetic drug injection)
changes in partial pressure of oxygen by arterial blood gas analysis
Time frame: within 5 minutes before start of anesthesia(anesthetic drug injection)
changes in concentrations of serum syndecan-1
Time frame: 1 hour after end of operation
changes in partial pressure of oxygen by arterial blood gas analysis
Time frame: 1 hour after end of operation
perioperative transfusion
Time frame: Intraoperation
perioperative transfusion
Time frame: Postoperative 48hours
intraoperative vasopressor use
Time frame: Intraoperation