NCT07508865 Sustainable Anesthesia in Myocardial Revascularization Surgery.
| NCT ID | NCT07508865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de La Frontera |
| Condition | Coronary Artery Bypass |
| Study Type | OBSERVATIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 116 participants in total. It began in 2024-07-02 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Introduction: Greenhouse gases threaten the health and safety of humanity. The Declaration of Helsinki seeks to protect human health and emphasizes the urgency of implementing sustainable strategies. Sustainability is defined by three pillars: economic (costs), social (clinical effectiveness), and environmental (environmental impact). Clinical effectiveness in cardiac surgery has a new paradigm: "optimized recovery," which translates into fewer complications, earlier extubation, shorter ICU stays, and potential cost reductions. The objective of this study is to compare the sustainability of the optimized recovery anesthetic technique with standard anesthetic practice in coronary artery bypass graft surgery, using a non-randomized interventional study design. * Methods: Patients aged 18 years or older with coronary artery disease scheduled for elective coronary artery bypass graft surgery will be recruited. Combined procedures and reinterventions will be excluded. Sample size: The optimized recovery group is expected to reduce postoperative mechanical ventilation by two hours. With a 95% confidence interval, 80% power, and a 1:3 ratio between the groups, a sample size of 29 and 87 patients was estimated for the optimized recovery and standard anesthesia groups, respectively. * The optimized recovery technique includes, preoperatively, oral pregabalin 75 mg, fasting, no benzodiazepines, total intravenous anesthesia, low-dose intravenous fentanyl, methadone 0.1-0.2 mg/kg IV, erector spinae plane block with 0.25% bupivacaine (20 mL per side), and postoperative nausea and vomiting prophylaxis with dexamethasone. Postoperatively, administer paracetamol 1 g IV every 6 hours, NSAIDs, and methadone 1 mg IV as needed. The standard anesthetic technique involves the anesthesiologist administering anesthesia as they have routinely done prior to the study, without changes. * Four anesthesiologists will participate in the study. Only one anesthesiologist will perform the OR technique, and their results will be compared with those of the other three, who will use their standard anesthetic technique. Patient assignment is independent, based on the hospital's schedule. * Analysis: The clinical effectiveness of each technique will be evaluated based on ICU extubation time. An economic analysis will be conducted based on average costs, and critical environmental impacts will be estimated through a life-cycle assessment. * Outcome: The performance of the indicator "Costs in Euros/CO2e/Extubation Time" will be studied. These will contribute to the estimation of an anesthetic strategy that addresses the challenges of sustainable medicine, reduces emissions, and enables the rational use of resources and their associated costs, offering environmentally friendly and clinically effective health solutions.
Eligibility Criteria
Inclusion Criteria: 1. Patients with coronary artery disease scheduled for coronary artery bypass graft surgery at Dr. Hernán Henríquez Aravena Hospital in Temuco. 2. Competent patients over 18 years of age, meaning they can easily understand the informed consent process and the characteristics of the study. 3. Elective interventions. Exclusion Criteria: 1. Interventions combined with other procedures or surgeries. 2. Reoperations or second cardiac or thoracic surgical interventions.
Contact & Investigator
Waldo Merino, MSc
PRINCIPAL INVESTIGATOR
Universidad de La Frontera
Frequently Asked Questions
Who can join the NCT07508865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Bypass. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07508865 currently recruiting?
Yes, NCT07508865 is actively recruiting participants. Contact the research team at waldo.merino@ufrontera.cl for enrollment information.
Where is the NCT07508865 trial being conducted?
This trial is being conducted at Temuco, Chile.
Who is sponsoring the NCT07508865 clinical trial?
NCT07508865 is sponsored by Universidad de La Frontera. The principal investigator is Waldo Merino, MSc at Universidad de La Frontera. The trial plans to enroll 116 participants.