Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- early prognosis (DVT Requiring Treatment)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes Assessor
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing diabetic foot limb amputation.
- •Patients aged 20 or older and who meet American Society of Anesthesiologists (ASA) physical class 3-4
Exclusion Criteria
- •patients with dementia or cognitive impairment
- •Patients who had previously undergone diabetic foot limb amputation within 1 month.
- •If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
- •pregnant or lactating women
- •Contraindications to nerve block (infection of the injection site, no cooperation, patient rejection, history of allergy ro local anesthetics)
- •Relative contraindications to general anesthesia (if difficult airways are expected, history of malignant hyperthermia, moderate or severe asthma)
Arms & Interventions
General anesthesia
General anesthesia involving intubation or supraglottic airway device insertion
Intervention: General anesthesia (Drug)
peripheral nerve block
popliteal sciatic nerve block
Intervention: Peripheral nerve block (Drug)
Outcomes
Primary Outcomes
early prognosis (DVT Requiring Treatment)
Time Frame: 30days after surgery
Indicate whether the patient has experienced a deep venous thrombosis (DVT) confirmed by doppler study, contrast study, or other study that required treatment.
early prognosis (Surgical Site Infection)
Time Frame: 30days after surgery
Indicate the extent of surgical site infection if one was present within 30 days of surgery.
early prognosis (New Central Neurological Event)
Time Frame: 30days after surgery
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.
early prognosis (Renal failure)
Time Frame: 30days after surgery
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.
early prognosis (Pneumonia)
Time Frame: 30days after surgery
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.
early prognosis (Myocardial Infarct)
Time Frame: 30days after surgery
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
early prognosis (mortality)
Time Frame: 30days after surgery
death within 30days after surgery
early prognosis (Respiratory failure)
Time Frame: 30days after surgery
Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
early prognosis (Delirium)
Time Frame: 30days after surgery
Indicate whether the patient experienced delirium in the postoperative period marked by illusions, confusion, cerebral excitement, and having a comparatively short course.
early prognosis (Unexpected return To The Operation Room)
Time Frame: 30days after surgery
Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit.
Secondary Outcomes
- changes in partial pressure of oxygen by arterial blood gas analysis(1 hour after end of operation)
- changes in concentrations of serum syndecan-1(1 hour after end of operation)
- perioperative transfusion(Postoperative 48hours)
- intraoperative vasopressor use(Intraoperation)