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The aim of this study was to compare
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator | General anesthesia involving intubation or supraglottic airway device insertion |
|
| peripheral nerve block | Experimental | popliteal sciatic nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia | Drug | 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. |
| 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:
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Seon Choi, MD, Ph.D | Contact | 82-2-2228-2412 | YSCHOI@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Yong Seon Choi | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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A Randomized, outcome assessor-Blinded, Trial
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Outcomes Assessor
|
| Peripheral nerve block | Drug | ultrasound-guided popliteal sciatic nerve block is performed |
|
| early prognosis (Myocardial Infarct) | Indicate if the patient experienced a MI postoperatively as evidenced by:
| 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:
| 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 |
| 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 |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |