Clinical trial NCT06953128: General Versus Regional Anesthesia in Vascular Surgery
Official title: Impact of General Versus Regional Anesthesia on the Incidence of Postoperative Pulmonary Complications in Peripheral Arterial Surgery: a Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Complications
Cardiovascular Diseases
Keywords: Postoperative Pulmonary Complications
Peripheral Arterial Disease
Spinal Anesthesia
General Anesthesia
Vascular Surgery
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Grupo Hospitalar Conceição
First posted: 2025-05-01
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Model Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention This model reflects the trial's aim to compare two standard anesthetic strategies in parallel groups to determine which is more effective in preventing postoperative pulmonary complications after peripheral arterial revascularization.
Primary purpose: TREATMENT

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 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.

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) anesthesia with spontaneous ventilation-on the incidence of postoperative pulmonary complications in patients undergoing elective peripheral arterial revascularization surgery. The study population will include 594 adult patients (ASA II-IV) with symptomatic critical limb ischemia, scheduled for elective lower limb revascularization at tertiary hospitals in Brazil. Patients will be randomized into two groups: Group 1 will receive spinal anesthesia with intravenous sedation and supplemental nasal oxygen; Group 2 will receive general anesthesia with controlled mechanical ventilation using lung-protective strategies (tidal volume 6-8 mL/kg and PEEP 5 cmH₂O).

The primary outcome is the incidence of postoperative pulmonary complications within 30 days after surgery or until hospital discharge. These include pneumonia, respiratory failure, pleural effusion, atelectasis, pneumothorax, aspiration pneumonitis, bronchospasm, ARDS, pulmonary embolism, and exacerbation of preexisting respiratory disease, defined according to internationally recognized criteria.

Secondary outcomes include:

1. major cardiovascular complications (nonfatal myocardial infarction, acute coronary syndrome, cardiogenic shock);
2. hemodynamic complications (prolonged hypotension or distributive shock requiring vasopressors);
3. other extrapulmonary complications such as acute kidney injury, stroke, delirium, sepsis, surgical limb complications (e.g., graft thrombosis, amputation), and thromboembolic events (e.g., DVT, PE);
4. ICU and hospital length of stay, PACU time, and 30-day or in-hospital mortality.

Data collection will include perioperative gasometric evaluation, detailed intraoperative hemodynamic and ventilatory monitoring, analgesia and antiemetic usage, and adverse events tracking through predefined time points (intraoperative, immediate postoperative, and up to 30 days after surgery). Sample size calculation is based on detecting a reduction in pulmonary complications from 25% in the general anesthesia group to 15% in the spinal anesthesia group, with a power of 80% and a two-tailed alpha of 0.05. Randomization will be performed using computer-generated block sequences, and outcome assessors and statisticians will be blinded. The statistical analysis will follow the intention-to-treat principle and include regression modeling to control for potential confounders such as comorbidities and operative duration.

The study will begin in July 2025 and is expected to be completed by December 2029. Results will be published in peer-reviewed journals and used to inform perioperative management strategies in vascular surgery.

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

Primary outcomes:
measure: Incidence of Postoperative Pulmonary Complications
timeFrame: Up to 30 days after surgery.
Secondary outcomes:
measure: Incidence of Major Cardiovascular Complications
timeFrame: Up to 30 days after surgery.
measure: Incidence of Hemodynamic Complications
timeFrame: Up to 24 hours after surgery.
measure: Incidence of Extrapulmonary Complications
timeFrame: Up to 30 days after surgery.
measure: Length of Stay in Post-Anesthesia Care Unit (PACU)
timeFrame: Up to 30 days after surgery.
measure: 30-Day Mortality
timeFrame: Up to 30 days after surgery.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Andre Prato Schmidt
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre (HCPA)
name: Andre P Schmidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt AP, Silvello D, Filho CTB, Bergmann D, Ferreira LEC, Nolasco MF, Pires TD, Braga WC, Andrade CF. Effects of Neuraxial or General Anesthesia on the Incidence of Postoperative Pulmonary Complications in Patients Undergoing Peripheral Vascular Surgery: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2025 Mar;39(3):724-732. doi: 10.1053/j.jvca.2024.12.027. Epub 2024 Dec 21.
citation: Schmidt AP, Marques AJ, Reinstein AR, Bevilacqua Filho CT, Carmona MJC, Auler JOC Jr, Felix EA, Andrade CF. Effects of protective mechanical ventilation during general anesthesia in patients undergoing peripheral vascular surgery: A randomized controlled trial. J Clin Anesth. 2020 May;61:109656. doi: 10.1016/j.jclinane.2019.109656. Epub 2019 Nov 26. No abstract available.
citation: Li A, Dreksler H, Nagpal SK, Brandys T, Jetty P, Dubois L, Parsons Leigh J, Stelfox HT, McIsaac DI, Roberts DJ. Outcomes After Neuraxial or Regional Anaesthesia Instead of General Anaesthesia for Lower Limb Revascularisation Surgery: A Systematic Review and Meta-Analysis of Randomised and Non-Randomised Studies. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):379-390. doi: 10.1016/j.ejvs.2022.10.046. Epub 2022 Nov 3.