General Versus Regional Anesthesia in Peripheral Arterial Surgery

Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of anesthesia to see which one might lead to fewer breathing problems after surgery for patients with poor blood flow in their legs. The trial will compare spinal anesthesia, which allows patients to breathe on their own, with general anesthesia, where patients are put on a breathing machine. The study will include around 594 adults who are scheduled for surgery to improve blood flow in their lower limbs. Researchers will track any lung-related issues that occur within 30 days after the surgery, as well as other health concerns, to determine which method of anesthesia is safer.

To be eligible for this trial, participants need to be at least 18 years old and have a specific type of leg condition called peripheral arterial disease. They should also be in good enough health (according to the ASA physical status II to IV) to undergo planned surgery. Patients who have certain health issues, like a very high body weight, a history of severe lung problems, or are currently on certain blood-thinning medications, might not be able to participate. If someone joins the trial, they can expect to receive either spinal or general anesthesia based on a random assignment, and they will be closely monitored to ensure their safety and health after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Able and willing to provide informed consent
• Exclusion Criteria:
• • Body mass index (BMI) \> 40 kg/m²
• • Emergency vascular surgery
• • History of lung resection surgery
• • Persistent hemodynamic instability preoperatively
• • History of bronchial asthma or chronic corticosteroid therapy
• • History of neuromuscular disorders
• • Current use of anticoagulants or antiplatelet agents contraindicating spinal anesthesia
• • Contraindications to spinal anesthesia (e.g., patient refusal, infection at puncture site, increased intracranial pressure, inability to cooperate due to agitation or cognitive impairment)
• • Acute vascular obstruction or other vascular complications not consistent with elective revascularization