Diabetic Foot
Conditions
Brief summary
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.
Interventions
DRUGGeneral anesthesia
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.
DRUGPeripheral nerve block
ultrasound-guided popliteal sciatic nerve block is performed
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor
Intervention model description
A Randomized, outcome assessor-Blinded, Trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early prognosis (Delirium) | 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 (DVT Requiring Treatment) | 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 (Myocardial Infarct) | 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 (Surgical Site Infection) | 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) | 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 (mortality) | 30days after surgery | death within 30days after surgery |
| early prognosis (Unexpected return To The Operation Room) | 30days after surgery | Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit. |
| early prognosis (Renal failure) | 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) | 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 (Respiratory failure) | 30days after surgery | Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation. |
Secondary
| Measure | Time frame |
|---|---|
| changes in partial pressure of oxygen by arterial blood gas analysis | within 5 minutes before start of anesthesia(anesthetic drug injection) |
| perioperative transfusion | Intraoperation |
| intraoperative vasopressor use | Intraoperation |
| changes in concentrations of serum syndecan-1 | within 5 minutes before start of anesthesia(anesthetic drug injection) |
Countries
South Korea
Contacts
Primary ContactYong Seon Choi, MD, Ph.D
Outcome results
None listed