Diabetic FootNCT04063046
Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
A study testing General anesthesia and Peripheral nerve block in people with Diabetic Foot, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- General anesthesia and Peripheral nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Nov 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
Yong Seon Choi, MD, Ph.D, 82-2-2228-2412, yschoi@yuhs.ac
About this study
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.
- Conditions
- Diabetic Foot
- Being tested
- General anesthesia, Peripheral nerve block
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaDrug
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 blockDrug
ultrasound-guided popliteal sciatic nerve block is performed
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | General anesthesia involving intubation or supraglottic airway device insertion Receives: Drug: General anesthesia |
| peripheral nerve block | Experimental | popliteal sciatic nerve block Receives: Drug: Peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
early prognosis (mortality)
death within 30days after surgery
Measured: 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.
Measured: 30days after surgery
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.
Measured: 30days after surgery
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.
Measured: 30days after surgery
early prognosis (Respiratory failure)
Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
Measured: 30days after surgery
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.
Measured: 30days after surgery
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
Measured: 30days after surgery
early prognosis (Surgical Site Infection)
Indicate the extent of surgical site infection if one was present within 30 days of surgery.
Measured: 30days after 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.
Measured: 30days after surgery
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.
Measured: 30days after surgery
Secondary outcomes (7)
changes in concentrations of serum syndecan-1
Measured: within 5 minutes before start of anesthesia(anesthetic drug injection)
changes in partial pressure of oxygen by arterial blood gas analysis
Measured: within 5 minutes before start of anesthesia(anesthetic drug injection)
changes in concentrations of serum syndecan-1
Measured: 1 hour after end of operation
changes in partial pressure of oxygen by arterial blood gas analysis
Measured: 1 hour after end of operation
perioperative transfusion
Measured: Intraoperation
perioperative transfusion
Measured: Postoperative 48hours
intraoperative vasopressor use
Measured: Intraoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start12 Nov 2019
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, outcome assessor-Blinded, Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Seon Choi, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063046
- Sponsor's protocol ID
- 4-2019-0613
- Status last verified
- Oct 2020
- First submitted
- 16 Aug 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT04063046
- Acronym / sponsor ID
- 4-2019-0613
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, outcome assessor-Blinded, Trial
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Drug: General anesthesiaGeneral anesthesia involving intubation or supraglottic airway device insertion |
| peripheral nerve block | Experimental | Drug: Peripheral nerve blockpopliteal sciatic nerve block |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaGeneral 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. | Drug | General anesthesia |
| Peripheral nerve blockultrasound-guided popliteal sciatic nerve block is performed | Drug | peripheral nerve block |
Primary outcome
early prognosis (mortality)
Time frame: 30days after surgery
death within 30days after surgery
early prognosis (Unexpected return To The Operation Room)
Time frame: 30days after surgery
Indicate whether the patient was unexpectedly returned to the Operation Room during this hospital visit.
early prognosis (Renal failure)
Time frame: 30days after surgery
Indicate whether the patient had acute renal failure or worsening renal function resulting in ONE OR BOTH of the following: 1. 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 2. A new requirement for dialysis postoperatively.
early prognosis (Pneumonia)
Time frame: 30days after surgery
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)
Time frame: 30days after surgery
Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.
early prognosis (DVT Requiring Treatment)
Time frame: 30days after surgery
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)
Time frame: 30days after surgery
Indicate if the patient experienced a MI postoperatively as evidenced by: 1. Transmural infarction: Defined by the appearance of a new Q wave in two or more contiguous leads on ECG, or 2. Subendocardial infarction: (non-Q wave) Infarction, which is considered present in a patient having clinical, angiographic, electrocardiographic, and/or 3. Laboratory biomarker (CPK,Troponin) evidence of myocardial necrosis with an ECG showing no new Q waves
early prognosis (Surgical Site Infection)
Time frame: 30days after surgery
Indicate the extent of surgical site infection if one was present within 30 days of surgery.
early prognosis (New Central Neurological Event)
Time frame: 30days after surgery
Indicate whether the patient experienced any of the following neurological events in the postoperative period that was not present preoperatively: 1. A central neurologic deficit persisting postoperatively for > 72 hours. 2. A postoperatively transient neurologic deficit (TIA recovery within 24 hours; RIND recovery within 72 hours). 3. 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)
Time frame: 30days after surgery
Indicate whether the patient experienced delirium in the postoperative period marked by illusions, confusion, cerebral excitement, and having a comparatively short course.
7 secondary outcomes
changes in concentrations of serum syndecan-1
Time frame: within 5 minutes before start of anesthesia(anesthetic drug injection)
changes in partial pressure of oxygen by arterial blood gas analysis
Time frame: within 5 minutes before start of anesthesia(anesthetic drug injection)
changes in concentrations of serum syndecan-1
Time frame: 1 hour after end of operation
changes in partial pressure of oxygen by arterial blood gas analysis
Time frame: 1 hour after end of operation
perioperative transfusion
Time frame: Intraoperation
perioperative transfusion
Time frame: Postoperative 48hours
intraoperative vasopressor use
Time frame: Intraoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Seon Choi principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia and Peripheral nerve block in people with Diabetic Foot, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Seon Choi, MD, Ph.D (82-2-2228-2412, YSCHOI@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early prognosis (mortality) (time frame: 30days after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.