General Versus Regional Anesthesia in Peripheral Arterial Surgery

NCT06953128 | Not Yet Recruiting

• 1 other identifier: 86625325.0.1001.5327
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Cardiovascular Diseases

Keywords

Postoperative Pulmonary Complications; Peripheral Arterial Disease; Spinal Anesthesia; General Anesthesia; Vascular Surgery

Outcome Measures

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.

  Up to 30 days after surgery.

Secondary Outcomes (5)

• Incidence of Major Cardiovascular Complications

  Up to 30 days after surgery.

• Incidence of Hemodynamic Complications

  Up to 24 hours after surgery.

• Incidence of Extrapulmonary Complications

  Up to 30 days after surgery.

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

  Up to 30 days after surgery.

• 30-Day Mortality

  Up to 30 days after surgery.

Study Arms (2)

Spinal Anesthesia

EXPERIMENTAL

Patients in this group will receive spinal (neuraxial) anesthesia with isobaric bupivacaine (15-20 mg) and intrathecal morphine (100 μg), with optional clonidine as an adjuvant. Sedation may be provided with intravenous midazolam, fentanyl, and/or propofol, as per anesthesiologist discretion. Supplemental oxygen will be administered via nasal cannula. Patients will breathe spontaneously and will not be mechanically ventilated.

Procedure: Spinal Anesthesia

General Anesthesia

ACTIVE COMPARATOR

Patients in this group will receive general anesthesia with intravenous induction (propofol or etomidate), opioids (remifentanil), and neuromuscular blockade (rocuronium), followed by endotracheal intubation and mechanical ventilation using a protective strategy (tidal volume 6-8 mL/kg predicted body weight and PEEP 5 cmH₂O). Anesthesia maintenance will include inhaled sevoflurane and continuous opioid infusion.

Procedure: General Anesthesia

Interventions

Spinal Anesthesia PROCEDURE

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.

Spinal Anesthesia

General Anesthesia PROCEDURE

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).

General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Grupo Hospitalar Conceição: collaborator

Study Sites (1)

Andre Prato Schmidt

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (3)

• 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.

  PMID: 39779428 BACKGROUND

• 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.

  PMID: 31784303 BACKGROUND

• 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.

  PMID: 36336286 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Cardiovascular Diseases; Peripheral Arterial Disease

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Andre P Schmidt, MD, PhD

  Hospital de Clínicas de Porto Alegre (HCPA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre P Schmidt, MD, PhD

CONTACT

5551996412212; apschmidt@hcpa.edu.br

Sabrina Coelli, MD

CONTACT

5551981481343; sabrina.coelli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blinded (Outcomes Assessor) Participants and anesthesiologists will not be blinded due to the nature of the interventions (general vs. spinal anesthesia). However, postoperative outcome assessors and statisticians performing data analysis will be blinded to group allocation to reduce detection and assessment bias. Randomization will be performed using a computer-generated block sequence and managed via the REDCap platform. Allocation concealment will be maintained using sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 1, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)