Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
NCT ID: NCT04063046
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
158 participants
INTERVENTIONAL
2019-11-12
2021-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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General anesthesia
General anesthesia involving intubation or supraglottic airway device insertion
General 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.
peripheral nerve block
popliteal sciatic nerve block
Peripheral nerve block
ultrasound-guided popliteal sciatic nerve block is performed
Interventions
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General 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.
Peripheral nerve block
ultrasound-guided popliteal sciatic nerve block is performed
Eligibility Criteria
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Inclusion Criteria
* 2\. Patients aged 20 or older and who meet American Society of Anesthesiologists (ASA) physical class 3-4
Exclusion Criteria
* 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)
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Yong Seon Choi
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2019-0613
Identifier Type: -
Identifier Source: org_study_id
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