Back to resultsEffect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
Primary Purpose
Diabetic Foot
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
General anesthesia
Peripheral nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
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)
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General anesthesia
peripheral nerve block
Arm Description
General anesthesia involving intubation or supraglottic airway device insertion
popliteal sciatic nerve block
Outcomes
Primary Outcome Measures
early prognosis (mortality)
death within 30days after surgery
early prognosis (Unexpected return To The Operation Room)
Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit.
early prognosis (Renal failure)
Indicate whether the patient had acute renal failure or worsening renal function resulting in ONE OR BOTH of the following:
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
A new requirement for dialysis postoperatively.
early prognosis (Pneumonia)
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 (Respiratory failure)
Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
early prognosis (DVT Requiring Treatment)
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 (Myocardial Infarct)
Indicate if the patient experienced a MI postoperatively as evidenced by:
Transmural infarction: Defined by the appearance of a new Q wave in two or more contiguous leads on ECG, or
Subendocardial infarction: (non-Q wave) Infarction, which is considered present in a patient having clinical, angiographic, electrocardiographic, and/or
Laboratory biomarker (CPK,Troponin) evidence of myocardial necrosis with an ECG showing no new Q waves
early prognosis (Surgical Site Infection)
Indicate the extent of surgical site infection if one was present within 30 days of surgery.
early prognosis (New Central Neurological Event)
Indicate whether the patient experienced any of the following neurological events in the postoperative period that was not present preoperatively:
A central neurologic deficit persisting postoperatively for > 72 hours.
A postoperatively transient neurologic deficit (TIA recovery within 24 hours; RIND recovery within 72 hours).
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 (Delirium)
Indicate whether the patient experienced delirium in the postoperative period marked by illusions, confusion, cerebral excitement, and having a comparatively short course.
Secondary Outcome Measures
changes in concentrations of serum syndecan-1
changes in partial pressure of oxygen by arterial blood gas analysis
changes in concentrations of serum syndecan-1
changes in partial pressure of oxygen by arterial blood gas analysis
perioperative transfusion
perioperative transfusion
intraoperative vasopressor use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04063046
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to compare
early prognosis (mortality, morbidity)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, outcome assessor-Blinded, Trial
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
General anesthesia involving intubation or supraglottic airway device insertion
Arm Title
peripheral nerve block
Arm Type
Experimental
Arm Description
popliteal sciatic nerve block
Intervention Type
Drug
Intervention Name(s)
General anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peripheral nerve block
Intervention Description
ultrasound-guided popliteal sciatic nerve block is performed
Primary Outcome Measure Information:
Title
early prognosis (mortality)
Description
death within 30days after surgery
Time Frame
30days after surgery
Title
early prognosis (Unexpected return To The Operation Room)
Description
Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit.
Time Frame
30days after surgery
Title
early prognosis (Renal failure)
Description
Indicate whether the patient had acute renal failure or worsening renal function resulting in ONE OR BOTH of the following:
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
A new requirement for dialysis postoperatively.
Time Frame
30days after surgery
Title
early prognosis (Pneumonia)
Description
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.
Time Frame
30days after surgery
Title
early prognosis (Respiratory failure)
Description
Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
Time Frame
30days after surgery
Title
early prognosis (DVT Requiring Treatment)
Description
Indicate whether the patient has experienced a deep venous thrombosis (DVT) confirmed by doppler study, contrast study, or other study that required treatment.
Time Frame
30days after surgery
Title
early prognosis (Myocardial Infarct)
Description
Indicate if the patient experienced a MI postoperatively as evidenced by:
Transmural infarction: Defined by the appearance of a new Q wave in two or more contiguous leads on ECG, or
Subendocardial infarction: (non-Q wave) Infarction, which is considered present in a patient having clinical, angiographic, electrocardiographic, and/or
Laboratory biomarker (CPK,Troponin) evidence of myocardial necrosis with an ECG showing no new Q waves
Time Frame
30days after surgery
Title
early prognosis (Surgical Site Infection)
Description
Indicate the extent of surgical site infection if one was present within 30 days of surgery.
Time Frame
30days after surgery
Title
early prognosis (New Central Neurological Event)
Description
Indicate whether the patient experienced any of the following neurological events in the postoperative period that was not present preoperatively:
A central neurologic deficit persisting postoperatively for > 72 hours.
A postoperatively transient neurologic deficit (TIA recovery within 24 hours; RIND recovery within 72 hours).
New postoperative coma that persists for at least 24 hours secondary to anoxic/ischemic and/or metabolic encephalopathy, thromboembolic event or cerebral bleed.
Time Frame
30days after surgery
Title
early prognosis (Delirium)
Description
Indicate whether the patient experienced delirium in the postoperative period marked by illusions, confusion, cerebral excitement, and having a comparatively short course.
Time Frame
30days after surgery
Secondary Outcome Measure Information:
Title
changes in concentrations of serum syndecan-1
Time Frame
within 5 minutes before start of anesthesia(anesthetic drug injection)
Title
changes in partial pressure of oxygen by arterial blood gas analysis
Time Frame
within 5 minutes before start of anesthesia(anesthetic drug injection)
Title
changes in concentrations of serum syndecan-1
Time Frame
1 hour after end of operation
Title
changes in partial pressure of oxygen by arterial blood gas analysis
Time Frame
1 hour after end of operation
Title
perioperative transfusion
Time Frame
Intraoperation
Title
perioperative transfusion
Time Frame
Postoperative 48hours
Title
intraoperative vasopressor use
Time Frame
Intraoperation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Seon Choi, MD, Ph.D
Phone
82-2-2228-2412
Email
YSCHOI@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Seon Choi
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Seon Choi, MD, Ph.D
Phone
82-2-2228-2412
Email
yschoi@yuhs.ac
12. IPD Sharing Statement
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Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
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