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General Versus Regional Anesthesia in Peripheral Arterial Surgery

ConditionsPostoperative ComplicationsCardiovascular Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre

About this trial

This multicenter, prospective, randomized clinical trial aims to compare the effects of spinal (neuraxial) anesthesia with spontaneous ventilation versus general anesthesia with mechanical ventilation on the incidence of postoperative pulmonary complications in adult patients undergoing elective lower limb revascularization surgery. A total of 594 patients with symptomatic peripheral arterial disease will be randomly assigned to receive either spinal anesthesia with sedation or general anesthesia with mechanical ventilation. The primary outcome is the incidence of postoperative pulmonary complications within 30 days or until hospital discharge, including pneumonia, respiratory failure, pleural effusion, atelectasis, and other defined respiratory events. Secondary outcomes include cardiovascular events, hemodynamic instability, renal injury, delirium, extrapulmonary complications, adverse events in the operated limb, ICU and hospital length of stay, and mortality. The study will be conducted at Hospital de Clínicas de Porto Alegre, Hospital Nossa Senhora da Conceição, and other participating Brazilian centers, with an expected start date in July 2025 and completion in December 2029.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 years

ASA physical status II to IV

Scheduled for elective peripheral arterial revascularization of the lower limbs

Diagnosis of symptomatic peripheral arterial disease with critical limb ischemia

Disqualifiers

Body mass index (BMI) > 40 kg/m²

Emergency vascular surgery

History of lung resection surgery

Persistent hemodynamic instability preoperatively

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Anesthesia

    Procedure/Surgery

    Participants will receive subarachnoid (spinal) anesthesia with 15-20 mg of isobaric bupivacaine 0.5% and 100 μg of intrathecal morphine. Clonidine (1 μg/kg) may be added at the discretion of the anesthesiologist. Sedation will be achieved with intravenous midazolam (up to 5 mg), fentanyl (up to 100 μg), and/or target-controlled infusion of propofol. Patients will remain spontaneously breathing throughout the procedure and receive supplemental oxygen via nasal cannula.

  • General Anesthesia

    Procedure/Surgery

    Participants will undergo general anesthesia induced with intravenous propofol (1.5-2.5 mg/kg) or etomidate (0.2-0.3 mg/kg), remifentanil (0.2-0.4 μg/kg/min), and rocuronium (0.6 mg/kg), followed by endotracheal intubation and controlled mechanical ventilation. Maintenance will include continuous remifentanil infusion and inhaled sevoflurane. Ventilation parameters will follow a protective strategy (tidal volume 6-8 mL/kg predicted body weight and PEEP of 5 cmH₂O).

Treatment groups

594 Participants
are divided into 2 treatment groups
Group A: Spinal AnesthesiaExperimental treatment 1 intervention
Group B: General AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Pulmonary Complications

Composite incidence of pulmonary complications occurring within 30 days after surgery or until hospital discharge. Events include: pneumonia, respiratory failure, pleural effusion, atelectasis, bronchospasm, aspiration pneumonitis, pneumothorax, pulmonary embolism, exacerbation of preexisting pulmonary disease, tracheobronchitis, and acute respiratory distress syndrome (ARDS), defined according to CDC and Berlin criteria.

Time frame
Up to 30 days after surgery.

Secondary outcomes

1

Incidence of Major Cardiovascular Complications

Composite outcome including non-fatal myocardial infarction, acute coronary syndrome, and cardiogenic shock occurring in the perioperative period, defined by standard clinical and laboratory criteria.

Time frame
Up to 30 days after surgery.
2

Incidence of Hemodynamic Complications

Incidence of distributive shock or persistent hypotension requiring vasopressor support during the perioperative period.

Time frame
Up to 24 hours after surgery.
3

Incidence of Extrapulmonary Complications

Includes sepsis, acute kidney injury, delirium, stroke, venous thromboembolism, and surgical limb events (e.g., vascular graft thrombosis, ischemia, amputation), defined according to standardized criteria.

Time frame
Up to 30 days after surgery.
4

Length of Stay in Post-Anesthesia Care Unit (PACU)

Total number of hours from the date of surgery to hospital discharge.

Time frame
Up to 30 days after surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Grupo Hospitalar Conceição

Collaborator

Source ClinicalTrials.gov

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