Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation

Study Overview
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Brief Summary
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The aim of this study was to compare early prognosis (mortality, morbidity) 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.

Official Title
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Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation

Conditions
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Diabetic Foot

Intervention / Treatment
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* Drug: General anesthesia
* Drug: Peripheral nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients undergoing diabetic foot limb amputation. 2. Patients aged 20 or older and who meet American Society of Anesthesiologists (ASA) physical class 3-4 Exclusion Criteria: 1. patients with dementia or cognitive impairment 2. Patients who had previously undergone diabetic foot limb amputation within 1 month. 3. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.) 4. pregnant or lactating women 5. Contraindications to nerve block (infection of the injection site, no cooperation, patient rejection, history of allergy ro local anesthetics) 6. Relative contraindications to general anesthesia (if difficult airways are expected, history of malignant hyperthermia, moderate or severe asthma)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, outcome assessor-Blinded, Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia<br>General anesthesia involving intubation or supraglottic airway device insertion | Drug: General anesthesia<br>* 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.<br>|
| Experimental: peripheral nerve block<br>popliteal sciatic nerve block | Drug: Peripheral nerve block<br>* ultrasound-guided popliteal sciatic nerve block is performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early prognosis (mortality) | death within 30days after surgery | 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. | 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: 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 A new requirement for dialysis postoperatively. | 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. | 30days after surgery | 
| early prognosis (Respiratory failure) | Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation. | 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. | 30days after surgery | 
| early prognosis (Myocardial Infarct) | Indicate if the patient experienced a MI postoperatively as evidenced by: Transmural infarction: Defined by the appearance of a new Q wave in two or more contiguous leads on ECG, or Subendocardial infarction: (non-Q wave) Infarction, which is considered present in a patient having clinical, angiographic, electrocardiographic, and/or Laboratory biomarker (CPK,Troponin) evidence of myocardial necrosis with an ECG showing no new Q waves | 30days after surgery | 
| early prognosis (Surgical Site Infection) | Indicate the extent of surgical site infection if one was present within 30 days of surgery. | 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: A central neurologic deficit persisting postoperatively for > 72 hours. A postoperatively transient neurologic deficit (TIA recovery within 24 hours; RIND recovery within 72 hours). New postoperative coma that persists for at least 24 hours secondary to anoxic/ischemic and/or metabolic encephalopathy, thromboembolic event or cerebral bleed. | 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. | 30days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in concentrations of serum syndecan-1 |  | within 5 minutes before start of anesthesia(anesthetic drug injection) | 
| changes in partial pressure of oxygen by arterial blood gas analysis |  | within 5 minutes before start of anesthesia(anesthetic drug injection) | 
| changes in concentrations of serum syndecan-1 |  | 1 hour after end of operation | 
| changes in partial pressure of oxygen by arterial blood gas analysis |  | 1 hour after end of operation | 
| perioperative transfusion |  | Intraoperation | 
| perioperative transfusion |  | Postoperative 48hours | 
| intraoperative vasopressor use |  | Intraoperation |