General versus regional Anesthesia complications

Impact of General versus Regional Anesthesia on the incidence of postoperative pulmonary complications in peripheral arterial surgery: a multicenter randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-88f3459

Enrollment

Unknown

Registered

2025-06-15

Start date

2025-07-15

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Interventions

This is a randomized controlled clinical trial with a total of 540 participants, patients scheduled for lower limb revascularization surgery. 270 will be randomly allocated to treatment with spinal ne

E03.155

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients; men or women; American Society of Anesthesiologists classification II to IV; aged >18 years; scheduled for elective arterial revascularization surgery in the lower limbs

Exclusion criteria

Exclusion criteria: Patientes with a body mass index above 40 kg/m2; those undergoing emergency surgery; with a history of lung surgery; persistent hemodynamic instability in the preoperative period; a history of asthma or chronic use of corticosteroid therapy; neuromuscular disorders; history of use of anticoagulants or antiplatelet agents in the preoperative period; other conditions that contraindicate spinal anesthesia will also be excluded from the study; patient refusal; infection at the puncture site for subarachnoid block; increased intracranial pressure; inability of the patient to cooperate due to agitation; cognitive impairment

Design outcomes

Primary

Measure	Time frame
Evaluate the effects of spinal anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of pulmonary complications (primary composite outcome: suspected respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia, tracheobronchitis, pulmonary thromboembolism, exacerbation of pre-existing pulmonary disorder, acute respiratory distress syndrome - ARDS) in the perioperative period of patients undergoing lower limb revascularization surgery	—

Measure

Time frame

Evaluate the effects of spinal anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of pulmonary complications (primary composite outcome: suspected respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia, tracheobronchitis, pulmonary thromboembolism, exacerbation of pre-existing pulmonary disorder, acute respiratory distress syndrome - ARDS) in the perioperative period of patients undergoing lower limb revascularization surgery

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Secondary

Measure	Time frame
- Evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of cardiovascular complications (secondary outcome composed of coronary syndrome events, non-fatal infarction and/or cardiogenic shock) in the perioperative period of patients undergoing lower limb revascularization surgery. - Evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of hemodynamic complications (secondary outcome composed of distributive shock or persistent hypotension requiring the use of vasoactive drugs) in the perioperative period of patients undergoing lower limb revascularization surgery. - Evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of various extrapulmonary complications, mortality within 30 days, length of stay in the post-anesthesia care unit, and length of hospital stay in patients undergoing lower limb revascularization surgery.	—

Measure

Time frame

- Evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of cardiovascular complications (secondary outcome composed of coronary syndrome events, non-fatal infarction and/or cardiogenic shock) in the perioperative period of patients undergoing lower limb revascularization surgery. - Evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of hemodynamic complications (secondary outcome composed of distributive shock or persistent hypotension requiring the use of vasoactive drugs) in the perioperative period of patients undergoing lower limb revascularization surgery. - Evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of various extrapulmonary complications, mortality within 30 days, length of stay in the post-anesthesia care unit, and length of hospital stay in patients undergoing lower limb revascularization surgery.

—

Countries

Brazil

Contacts

Public ContactSabrina Coelli

Hospital de Clínicas de Porto Alegre

sabrina_coelli@hotmail.com+55(51) 3359-8000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)