Heart Bypass Surgery Clinical Trials

Clinical trials related to Heart Bypass Surgery Procedure

Sustainable Anesthesia in Myocardial Revascularization Surgery: a Non-randomized Interventional Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with coronary artery disease scheduled for coronary artery bypass graft surgery at Dr. Hernán Henríquez Aravena Hospital in Temuco.

• Competent patients over 18 years of age, meaning they can easily understand the informed consent process and the characteristics of the study.

• Elective interventions.

Locations
Other Locations
Chile
Hospital Hernán Henríquez Aravena
RECRUITING
Temuco
Contact Information
Primary
Waldo Merino, MSc
waldo.merino@ufrontera.cl
+56974954831
Backup
Claudio Cárcamo, MSc
Claudio.carcamo@ufrontera.cl
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 116
Treatments
Optimized recovery
A sustainable anesthetic technique for myocardial revascularization surgery to reduce costs, mitigate its environmental impact, and achieve the best clinical effectiveness in terms of extubation time.
Standard Anesthetic Practice
The common practice or routine anesthetic practice
Sponsors
Leads: Universidad de La Frontera

This content was sourced from clinicaltrials.gov