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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063046
• Other study ID #: 4-2019-0613
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: September 2021

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: Yong Seon Choi, MD, Ph.D
• Phone: 82-2-2228-2412
• Email: YSCHOI[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 undergoing limb amputation surgery as a prospective randomized trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: September 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early prognosis (mortality)	death within 30days after surgery	30days after surgery
Primary	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
Primary	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.	30days after surgery
Primary	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
Primary	early prognosis (Respiratory failure)	Indicate whether the patient experienced respiratory failure in the postoperative period requiring mechanical ventilation and/or reintubation.	30days after surgery
Primary	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
Primary	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	30days after surgery
Primary	early prognosis (Surgical Site Infection)	Indicate the extent of surgical site infection if one was present within 30 days of surgery.	30days after surgery
Primary	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.	30days after surgery
Primary	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	changes in concentrations of serum syndecan-1		within 5 minutes before start of anesthesia(anesthetic drug injection)
Secondary	changes in partial pressure of oxygen by arterial blood gas analysis		within 5 minutes before start of anesthesia(anesthetic drug injection)
Secondary	changes in concentrations of serum syndecan-1		1 hour after end of operation
Secondary	changes in partial pressure of oxygen by arterial blood gas analysis		1 hour after end of operation
Secondary	perioperative transfusion		Intraoperation
Secondary	perioperative transfusion		Postoperative 48hours
Secondary	intraoperative vasopressor use		Intraoperation