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

Yonsei University

Status: Unknown

Conditions: Diabetic Foot

Treatments: Drug: Peripheral nerve block; Drug: General anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04063046

4-2019-0613

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

General anesthesia

Active Comparator group

Description:

General anesthesia involving intubation or supraglottic airway device insertion

Treatment:

Drug: General anesthesia

peripheral nerve block

Experimental group

Description:

popliteal sciatic nerve block

Treatment:

Drug: Peripheral nerve block