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

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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.
    1. 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
    1. Patients who had previously undergone diabetic foot limb amputation within 1 month.
    1. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
    1. pregnant or lactating women
    1. Contraindications to nerve block (infection of the injection site, no cooperation, patient rejection, history of allergy ro local anesthetics)
    1. 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

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

Trial contacts and locations

1

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Central trial contact

Yong Seon Choi, MD, Ph.D

Data sourced from clinicaltrials.gov

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