Postoperative ComplicationsGENERANCT06953128
General Versus Regional Anesthesia in Peripheral Arterial Surgery
A study testing Spinal Anesthesia and General Anesthesia in people with Postoperative Complications and Cardiovascular Diseases, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Cardiovascular Diseases
- What is being tested?
- Spinal Anesthesia and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of General Versus Regional Anesthesia on the Incidence of Postoperative Pulmonary Complications in Peripheral Arterial Surgery: a Multicenter Randomized Clinical Trial
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.
Read the 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:
- major cardiovascular complications (nonfatal myocardial infarction, acute coronary syndrome, cardiogenic shock);
- hemodynamic complications (prolonged hypotension or distributive shock requiring vasopressors);
- 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);
- 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.
- Being tested
- Spinal Anesthesia, General Anesthesia
- Keywords
- Postoperative Pulmonary Complications, Peripheral Arterial Disease, Spinal Anesthesia, General Anesthesia, Vascular Surgery
- Medical subject headings
- Postoperative Complications, Cardiovascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
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.
General AnesthesiaProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after surgery.
Secondary outcomes (5)
Incidence of Major Cardiovascular Complications
Composite outcome including non-fatal myocardial infarction, acute coronary syndrome, and cardiogenic shock occurring in the perioperative period, defined by standard clinical and laboratory criteria.
Measured: Up to 30 days after surgery.
Incidence of Hemodynamic Complications
Incidence of distributive shock or persistent hypotension requiring vasopressor support during the perioperative period.
Measured: Up to 24 hours after surgery.
Incidence of Extrapulmonary Complications
Includes sepsis, acute kidney injury, delirium, stroke, venous thromboembolism, and surgical limb events (e.g., vascular graft thrombosis, ischemia, amputation), defined according to standardized criteria.
Measured: Up to 30 days after surgery.
Length of Stay in Post-Anesthesia Care Unit (PACU)
Total number of hours from the date of surgery to hospital discharge.
Measured: Up to 30 days after surgery.
30-Day Mortality
All-cause mortality occurring within 30 days after surgery.
Measured: Up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Hospitalar Conceição
- Responsible party
- Sponsor
- Investigators
- Andre P Schmidt, MD, PhD, Principal investigator, Hospital de Clínicas de Porto Alegre (HCPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953128
- Sponsor's protocol ID
- 86625325.0.1001.5327
- Acronym
- GENERA
- Status last verified
- Jun 2025
- First submitted
- 14 Apr 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to Share Individual Participant Data (IPD)? - No IPD Sharing Description: * The individual participant data (IPD) collected during the study will not be made publicly available due to ethical considerations and patient confidentiality. * Plan to Share IPD with Other Researchers? No * Available Supporting Information: Not applicable \- Time Frame and Access Criteria: Not applicable
Publications
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.
PubMed 39779428Schmidt 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.
PubMed 31784303Li 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.
PubMed 36336286
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of General Versus Regional Anesthesia on the Incidence of Postoperative Pulmonary Complications in Peripheral Arterial Surgery: a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06953128
- Acronym / sponsor ID
- GENERA / 86625325.0.1001.5327
- Keywords
- Postoperative Pulmonary Complications, Peripheral Arterial Disease, Spinal Anesthesia, General Anesthesia, Vascular Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Grupo Hospitalar Conceição
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- major cardiovascular complications (nonfatal myocardial infarction, acute coronary syndrome, cardiogenic shock);
- hemodynamic complications (prolonged hypotension or distributive shock requiring vasopressors);
- 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);
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Experimental | Procedure: Spinal AnesthesiaPatients 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. |
| General Anesthesia | Active comparator | Procedure: General AnesthesiaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal AnesthesiaParticipants 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. | Procedure or surgery | Spinal Anesthesia |
| General AnesthesiaParticipants 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). | Procedure or surgery | General Anesthesia |
Primary outcome
Incidence of Postoperative Pulmonary Complications
Time frame: Up to 30 days after surgery.
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.
5 secondary outcomes
Incidence of Major Cardiovascular Complications
Time frame: Up to 30 days after surgery.
Incidence of Hemodynamic Complications
Time frame: Up to 24 hours after surgery.
Incidence of Extrapulmonary Complications
Time frame: Up to 30 days after surgery.
Length of Stay in Post-Anesthesia Care Unit (PACU)
Time frame: Up to 30 days after surgery.
30-Day Mortality
Time frame: Up to 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 39779428Schmidt 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.
- Results publication: PubMed 31784303Schmidt 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.
- Results publication: PubMed 36336286Li 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.
- Individual participant dataSharing planned: No. Plan to Share Individual Participant Data (IPD)? - No IPD Sharing Description: * The individual participant data (IPD) collected during the study will not be made publicly available due to ethical considerations and patient confidentiality. * Plan to Share IPD with Other Researchers? No * Available Supporting Information: Not applicable - Time Frame and Access Criteria: Not applicable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andre P Schmidt, MD, PhD principal investigator
Hospital de Clínicas de Porto Alegre (HCPA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia and General Anesthesia in people with Postoperative Complications and Cardiovascular Diseases, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre P Schmidt, MD, PhD (5551996412212, apschmidt@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Pulmonary Complications (time frame: Up to 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953128, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.