[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589339":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002For propofol, as per anesthesiologist discretion. Supplemental oxygen will be administered via nasal cannula. Patients will breathe spontaneously and will not be mechanically ventilated.",[13],"Procedure: Spinal Anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"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\u002Fkg predicted body weight and PEEP 5 cmH₂O). Anesthesia maintenance will include inhaled sevoflurane and continuous opioid infusion.",[19],"Procedure: General Anesthesia",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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\u002Fkg) 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\u002For target-controlled infusion of propofol. Patients will remain spontaneously breathing throughout the procedure and receive supplemental oxygen via nasal cannula.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants will undergo general anesthesia induced with intravenous propofol (1.5-2.5 mg\u002Fkg) or etomidate (0.2-0.3 mg\u002Fkg), remifentanil (0.2-0.4 μg\u002Fkg\u002Fmin), and rocuronium (0.6 mg\u002Fkg), 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\u002Fkg predicted body weight and PEEP of 5 cmH₂O).",[15],[30],{"name":31,"affiliation":32,"role":33},"Andre P Schmidt, MD, PhD","Hospital de Clínicas de Porto Alegre (HCPA)","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","5551996412212","apschmidt@hcpa.edu.br",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Sabrina Coelli, MD","5551981481343","sabrina.coelli@gmail.com",[44],{"facility":45,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"Andre Prato Schmidt","Porto Alegre","Rio Grande do Sul","90035903","Brazil","BR",{"type":52,"coordinates":53},"Point",[54,55],-51.23019,-30.03283,{"lat":55,"lon":54},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60],{"name":61,"class":62},"Grupo Hospitalar Conceição","OTHER_GOV","100589339","general-versus-regional-anesthesia-in-peripheral-arterial-surgery-100589339",false,"NCT06953128","General Versus Regional Anesthesia in Peripheral Arterial Surgery","Impact of General Versus Regional Anesthesia on the Incidence of Postoperative Pulmonary Complications in Peripheral Arterial Surgery: a Multicenter Randomized Clinical Trial","GENERA","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* ASA physical status II to IV\n* Scheduled for elective peripheral arterial revascularization of the lower limbs\n* Diagnosis of symptomatic peripheral arterial disease with critical limb ischemia\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\> 40 kg\u002Fm²\n* Emergency vascular surgery\n* History of lung resection surgery\n* Persistent hemodynamic instability preoperatively\n* History of bronchial asthma or chronic corticosteroid therapy\n* History of neuromuscular disorders\n* Current use of anticoagulants or antiplatelet agents contraindicating spinal anesthesia\n* Contraindications to spinal anesthesia (e.g., patient refusal, infection at puncture site, increased intracranial pressure, inability to cooperate due to agitation or cognitive impairment)\n* Acute vascular obstruction or other vascular complications not consistent with elective revascularization","ALL","18 Years",{"count":74,"type":75},594,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82],"Postoperative Complications","Cardiovascular Diseases",[84,85,9,15,86],"Postoperative Pulmonary Complications","Peripheral Arterial Disease","Vascular Surgery","NOT_YET_RECRUITING","2025-06-23",{"date":90,"type":91},"2025-06-26","ACTUAL",{"date":93,"type":75},"2025-07-01",{"date":95,"type":75},"2028-06-30",{"name":5,"class":6},1]