Status:
NOT_YET_RECRUITING
General Versus Regional Anesthesia in Peripheral Arterial Surgery
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Grupo Hospitalar Conceição
Conditions:
Postoperative Complications
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This multicenter, prospective, randomized clinical trial aims to compare the effects of spinal (neuraxial) anesthesia with spontaneous ventilation versus general anesthesia with mechanical ventilation...
Detailed Description
This is a prospective, randomized, multicenter clinical trial designed to evaluate the impact of the anesthetic technique-general anesthesia with mechanical ventilation versus spinal (neuraxial) anest...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT06953128
Start Date
July 1 2025
End Date
June 30 2028
Last Update
June 26 2025
Active Locations (1)
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1
Andre Prato Schmidt
Porto Alegre, Rio Grande do Sul, Brazil, 90035903