Clinical trial NCT04063046: Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
Official title: Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, outcome assessor-Blinded, Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: early prognosis (mortality)
timeFrame: 30days after surgery
measure: early prognosis (Unexpected return To The Operation Room)
timeFrame: 30days after surgery
measure: early prognosis (Renal failure)
timeFrame: 30days after surgery
measure: early prognosis (Pneumonia)
timeFrame: 30days after surgery
measure: early prognosis (Respiratory failure)
timeFrame: 30days after surgery
measure: early prognosis (DVT Requiring Treatment)
timeFrame: 30days after surgery
measure: early prognosis (Myocardial Infarct)
timeFrame: 30days after surgery
measure: early prognosis (Surgical Site Infection)
timeFrame: 30days after surgery
measure: early prognosis (New Central Neurological Event)
timeFrame: 30days after surgery
measure: early prognosis (Delirium)
timeFrame: 30days after surgery
Secondary outcomes:
measure: changes in concentrations of serum syndecan-1
timeFrame: within 5 minutes before start of anesthesia(anesthetic drug injection)
measure: changes in partial pressure of oxygen by arterial blood gas analysis
timeFrame: within 5 minutes before start of anesthesia(anesthetic drug injection)
measure: changes in concentrations of serum syndecan-1
timeFrame: 1 hour after end of operation
measure: changes in partial pressure of oxygen by arterial blood gas analysis
timeFrame: 1 hour after end of operation
measure: perioperative transfusion
timeFrame: Intraoperation
measure: perioperative transfusion
timeFrame: Postoperative 48hours
measure: intraoperative vasopressor use
timeFrame: Intraoperation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Yong Seon Choi
role: PRINCIPAL_INVESTIGATOR
References: