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

NCT04063046 | Unknown

• 1 other identifier: 4-2019-0613
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare

1. 1.early prognosis (mortality, morbidity)
2. 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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (10)

• early prognosis (mortality)

  death within 30days after surgery

  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.

  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: 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.

  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.

  30days after surgery

• early prognosis (Respiratory failure)

  Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.

  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.

  30days after surgery

• early prognosis (Myocardial Infarct)

  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

  30days after surgery

• early prognosis (Surgical Site Infection)

  Indicate the extent of surgical site infection if one was present within 30 days of surgery.

  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: 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.

  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.

  30days after surgery

Secondary Outcomes (7)

• changes in concentrations of serum syndecan-1

  within 5 minutes before start of anesthesia(anesthetic drug injection)

• changes in partial pressure of oxygen by arterial blood gas analysis

  within 5 minutes before start of anesthesia(anesthetic drug injection)

• changes in concentrations of serum syndecan-1

  1 hour after end of operation

• changes in partial pressure of oxygen by arterial blood gas analysis

  1 hour after end of operation

• perioperative transfusion

  Intraoperation

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

General anesthesia involving intubation or supraglottic airway device insertion

Drug: General anesthesia

peripheral nerve block

EXPERIMENTAL

popliteal sciatic nerve block

Drug: Peripheral nerve block

Interventions

General anesthesia DRUG

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.

General anesthesia

Peripheral nerve block DRUG

ultrasound-guided popliteal sciatic nerve block is performed

peripheral nerve block

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients undergoing diabetic foot limb amputation.
• \. Patients aged 20 or older and who meet American Society of Anesthesiologists (ASA) physical class 3-4

You may not qualify if:

• \. patients with dementia or cognitive impairment
• \. Patients who had previously undergone diabetic foot limb amputation within 1 month.
• \. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
• \. pregnant or lactating women
• \. Contraindications to nerve block (infection of the injection site, no cooperation, patient rejection, history of allergy ro local anesthetics)
• \. Relative contraindications to general anesthesia (if difficult airways are expected, history of malignant hyperthermia, moderate or severe asthma)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Yong Seon Choi

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Seon Choi, MD, Ph.D

CONTACT

82-2-2228-2412; YSCHOI@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized, outcome assessor-Blinded, Trial

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 21, 2019
• Study Start: November 12, 2019
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

KR (1)