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

Not Applicable

• Conditions: Diabetic Foot
• Interventions: Drug: General anesthesia; Drug: Peripheral nerve block

• Registration Number: NCT04063046
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Study Start: 2019-11-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14
• Primary Completion: 2021-07
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	General anesthesia	General anesthesia involving intubation or supraglottic airway device insertion
peripheral nerve block	Peripheral nerve block	popliteal sciatic nerve block

Primary Outcome Measures

Name	Time	Method
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 (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 (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 (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 (mortality)	30days after surgery	death within 30days after surgery
early prognosis (Respiratory failure)	30days after surgery	Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
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 (Unexpected return To The Operation Room)	30days after surgery	Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of