Sustainable Anesthesia in Myocardial Revascularization Surgery.

NCT07508865 | Recruiting

• 1 other identifier: EINR2024
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass; Anesthesia; Sustainability

Keywords

sustainability; myocardial revascularization surgery; Enhanced recovery after surgery; life cycle assessment; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Sustainability result

  To make an appropriate comparison, the average values of the ratio for each anesthetic strategy or intervention will be considered, interms of: • Costs (Euros)/Carbon Footprint (CO2e)/Time elapsed until extubation (min).

  From the moment he enters the operating room until the endotracheal tube is removed in the ICU.

Secondary Outcomes (3)

• Clinical effectiveness

  Time elapsed from the patient's admission to the ICU until their extubation for each intervention, in minutes.

• Environmental Impact Analysis

  Time elapsed from the patient's entry into the operating room until their exit.

• Cost analysis

  Time elapsed from the patient's entry into the operating room until their exit.

Other Outcomes (1)

• Harm/benefit to human health.

  From the moment he enters the operating room until the endotracheal tube is removed in the ICU.

Study Arms (2)

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.

Procedure: Optimized recovery

Standard Anesthetic Practice

The common practice or routine anesthetic practice

Other: Standard Anesthetic Practice

Interventions

Optimized recovery PROCEDURE

Preoperative: Initiate oral pregabalin 75 mg the night before surgery. Fast from light food for 6 hours preoperatively. 2 hours of clear liquids. Do not administer benzodiazepines preoperatively. Intraoperative: Induction and maintenance of anesthesia with propofol. Opioids: intravenous (IV) fentanyl as required, methadone 0.2 mg/kg IV once. Post-induction: Erector spinae plane block with 0.25% bupivacaine solution, 20 ml per side, once. Prophylaxis of postoperative nausea and vomiting with dexamethasone 8 mg IV once in non-diabetic patients or 4 mg IV once in diabetic patients. Intraoperative intravenous analgesia: Metamizole IV every 6 hours. Low flow rates of clinical gases (oxygen and air).

Optimized recovery

Standard Anesthetic Practice OTHER

The common practice or the standard practice anesthetic technique involves the anesthesiologist administering anesthesia routinely, without changes.

Standard Anesthetic Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Interventions combined with other procedures or surgeries.
• Reoperations or second cardiac or thoracic surgical interventions.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Hospital Hernán Henríquez Aravena

Temuco, Región de la Araucanía, Chile

RECRUITING

Related Publications (11)

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  PMID: 39532374 BACKGROUND

• Kubitz JC, Schubert AM, Schulte-Uentrop L. [Enhanced recovery after surgery (ERAS(R)) in cardiac anesthesia]. Anaesthesiologie. 2022 Sep;71(9):663-673. doi: 10.1007/s00101-022-01190-z. Epub 2022 Aug 20. German.

  PMID: 35987897 BACKGROUND

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  PMID: 34411226 BACKGROUND

• Sherman JD, Thiel C, MacNeill A, Eckelman MJ, Dubrow R, Hopf H, et al. The Green Print: Advancement of Environmental Sustainability in Healthcare. Resources, Conservation and Recycling. Elsevier B.V.; 2020. doi:10.1016/j.resconrec.2020.104882

  BACKGROUND

• MacNeill AJ, Lillywhite R, Brown CJ. The impact of surgery on global climate: a carbon footprinting study of operating theatres in three health systems. Lancet Planet Health. 2017 Dec;1(9):e381-e388. doi: 10.1016/S2542-5196(17)30162-6. Epub 2017 Dec 8.

  PMID: 29851650 BACKGROUND

• Wyssusek K, Chan KL, Eames G, Whately Y. Greenhouse gas reduction in anaesthesia practice: a departmental environmental strategy. BMJ Open Qual. 2022 Aug;11(3):e001867. doi: 10.1136/bmjoq-2022-001867.

  PMID: 36002191 BACKGROUND

• Drew J, Christie SD, Tyedmers P, Smith-Forrester J, Rainham D. Operating in a Climate Crisis: A State-of-the-Science Review of Life Cycle Assessment within Surgical and Anesthetic Care. Environ Health Perspect. 2021 Jul;129(7):76001. doi: 10.1289/EHP8666. Epub 2021 Jul 12.

  PMID: 34251875 BACKGROUND

• Eckelman MJ, Sherman JD. Estimated Global Disease Burden From US Health Care Sector Greenhouse Gas Emissions. Am J Public Health. 2018 Apr;108(S2):S120-S122. doi: 10.2105/AJPH.2017.303846. Epub 2017 Oct 26.

  PMID: 29072942 BACKGROUND

• Halonen JI, Erhola M, Furman E, Haahtela T, Jousilahti P, Barouki R, Bergman A, Billo NE, Fuller R, Haines A, Kogevinas M, Kolossa-Gehring M, Krauze K, Lanki T, Vicente JL, Messerli P, Nieuwenhuijsen M, Paloniemi R, Peters A, Posch KH, Timonen P, Vermeulen R, Virtanen SM, Bousquet J, Anto JM. The Helsinki Declaration 2020: Europe that protects. Lancet Planet Health. 2020 Nov;4(11):e503-e505. doi: 10.1016/S2542-5196(20)30242-4. No abstract available.

  PMID: 33159874 BACKGROUND

• Halonen JI, Erhola M, Furman E, Haahtela T, Jousilahti P, Barouki R, Bergman A, Billo NE, Fuller R, Haines A, Kogevinas M, Kolossa-Gehring M, Krauze K, Lanki T, Vicente JL, Messerli P, Nieuwenhuijsen M, Paloniemi R, Peters A, Posch KH, Timonen P, Vermeulen R, Virtanen SM, Bousquet J, Anto JM. A call for urgent action to safeguard our planet and our health in line with the helsinki declaration. Environ Res. 2021 Feb;193:110600. doi: 10.1016/j.envres.2020.110600. Epub 2020 Dec 9.

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• Seifert C, Koep L, Wolf P, Guenther E. Life cycle assessment as decision support tool for environmental management in hospitals: A literature review. Health Care Manage Rev. 2021 Jan/Mar;46(1):12-24. doi: 10.1097/HMR.0000000000000248.

  PMID: 31116121 BACKGROUND

Study Officials

• Waldo Merino, MSc

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waldo Merino, MSc

CONTACT

+56974954831; waldo.merino@ufrontera.cl

Claudio Cárcamo, MSc

CONTACT

Claudio.carcamo@ufrontera.cl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 2, 2026
• Study Start: July 2, 2024
• Primary Completion: April 30, 2026
• Study Completion: May 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CL (1)