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Coronary Artery BypassNCT07508865

Sustainable Anesthesia in Myocardial Revascularization Surgery.

An observational study of Coronary Artery Bypass and Anesthesia, run by Universidad de La Frontera at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Bypass, Anesthesia, Sustainability
What is being tested?
Optimized recovery and Standard Anesthetic Practice
How many people
116 participants
Where
1 siteChile
Study dates
2 Jul 2024to 30 May 2026
How long will I take part?
1 Day
Phase
Observational
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

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Waldo Merino, MSc contact

+56974954831

waldo.merino@ufrontera.cl

Claudio Cárcamo, MSc contact

Claudio.carcamo@ufrontera.cl

Chile1 site, 1 recruiting
  • Hospital Hernán Henríquez Aravena

    Temuco, Araucania

    Mauricio Peña, MSc, +56984088346, penafernandezmauricio@hotmail.com

    Waldo Merino, MSc

    Recruiting

Other trials in Chile

About this study

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

  • 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.
Read the detailed description

I• Introduction:

Today, it is clear that protecting human health without ensuring a healthy environment is counterproductive. The 2020 Helsinki Declaration calls for "awareness of the strong interrelationship between human and planetary health". Due to greenhouse gases (GHG), we face the so-called "climate emergency," as climate change threatens the health and security of humanity. However, the healthcare industry is one of the main sources of pollutants and GHG. In the US, the healthcare sector alone is responsible for 9-10% of national GHG emissions and other toxic emissions, amounting to 123,000-381,000 DALYs per year (Disability-Adjusted Life Years). Hospitals account for significant resource consumption and waste and are responsible for almost half of the healthcare sector's GHG emissions. In the healthcare sector, operating rooms account for at least 30% of a hospital's total waste. In a hospital, emissions from anesthetic procedures stand out due to the use of certain drugs and clinical gases, which alone can account for more than 45% of a high-complexity center's CO2e emissions. Therefore, environmental sustainability is becoming a crucial aspect for anesthesiology.

To assess the environmental impact of a clinical practice, a life-cycle assessment (LCA) is necessary. This is an environmental evaluation of products, systems, or services that quantifies the environmental impacts generated throughout their life cycle. CO2e emissions are the most important impact indicator or category due to their role in climate change, harm to human health (expressed in DALY), damage to ecosystems, and resource depletion. Life cycle assessment studies of clinical services include: childbirth procedures, hysterectomy, hemodialysis and peritoneal dialysis, plastic surgery, cataract extraction, laparoscopic procedures, and intensive care.

Within medical and surgical services, myocardial revascularization surgery is one of the procedures that uses the most operating room resources, a space where the highest GHG emissions have been reported, with the greatest resource and energy consumption.

On the other hand, clinical effectiveness in relation to the perioperative period, of myocardial revascularization surgery, has a new paradigm especially for anesthesiology: "enhanced recovery" or "optimized recovery" has has been associated with a decrease in postoperative respiratory complications and a greater likelihood of early extubation, shortening stays in intensive care units and hospitals, which could be reflected in lower costs associated with this type of care.

Sustainability is defined by three pillars: economic, social, and environmental dimensions. Thus, a sustainable anesthetic strategy for coronary heart surgery, compared to other anesthetic techniques, would aim for a reduction in current costs (economic), mitigate its impact by identifying critical points of CO2 emissions (environmental impact), and achieve better clinical effectiveness with an optimized recovery anesthetic strategy in terms of extubation time (social dimension). This is the problem we wish to address: how to make anesthetic practice sustainable by studying an optimized recovery technique in one of the most complex and resource-intensive surgical procedures, myocardial revascularization.

  • Methods

General objective:

To establish the relative sustainability of the optimized recovery anesthetic technique with respect to the usual anesthetic practice in myocardial revascularization surgery performed at the Hernán Henríquez Aravena Hospital in Temuco.

Specific objectives:

  1. To identify the differences in clinical effectiveness in postoperative recovery, specifically regarding early extubation, between the two anesthetic strategies.
  2. To identify the critical points in the life cycle analysis of standard anesthetic practice and the optimized recovery anesthetic strategy in myocardial revascularization surgeries.
  3. To understand the cost behavior of standard anesthetic practice and the optimized recovery anesthetic strategy in myocardial revascularization surgeries performed.
  4. Estimate the damage to human health, DALYs, generated by the environmental critical points of the life cycles of the usual anesthetic practice and the optimized recovery anesthetic strategy in myocardial revascularization surgeries.

This project will conduct a non-randomized interventional study and implement an optimized anesthetic recovery strategy for coronary artery bypass graft surgery. This study will perform a sustainability analysis of an optimized recovery anesthetic technique compared to a usual anesthetic practice for myocardial revascularization surgery at the Hernán Henríquez Aravena Hospital in Temuco (HHHA).

The anesthetic strategies to be compared are common practice or standard anesthetic practice (SAP) and the proposed optimized recovery (OR) approach.

The sample size calculation is based on the primary variable, the number of hours of mechanical ventilation (extubation time), comparing SAP with the OR approach. The expected mean and standard deviation for SAP were obtained from the cardiovascular ICU's continuous record database for a six-month period in 2023: 4.6 hours and 3.3 hours, respectively. OR is expected to reduce the mean time by 2 hours while maintaining the same recorded variability. For the sample size calculation, a 95% confidence level, 80% statistical power, and a 1:3 ratio, a sample size of 29 patients was estimated for the OR group and 87 for the SAP group, for a total of 116 patients.

Feasibility and Sampling: The hospital performs 500 cardiac surgeries annually, 350 of which are coronary artery bypass grafts. Patients will be selected consecutively. Allocation method: Four anesthesiologists will be included in the study. Only one anesthesiologist will perform the OR technique, and the results will be compared with those of the other three, who will apply their SAP. The selection of the single anesthesiologist who will perform the procedure will be based on convenience. Masking: Anesthesiologists not exposed to the procedure will continue to administer anesthesia using their usual technique, on days other than the day the OR technique is performed, independently of the patients' surgical schedule. The anesthesiologist will be masked for data analysis.

Clinical variables: Patient variables: age, weight, and height. Medical history or concomitant pathology. Anesthesia variables: drugs used, anesthesia duration, resources, and energy used. Surgical variables: number of coronary artery bypass grafts, surgical time, and length of stay in the operating room. ICU variables: extubation time and length of stay in the ICU.

Data Collection: Data and information on supplies will be obtained from the hospital database and directly collected during each procedure, after obtaining informed consent. Only the outcome variable, ICU extubation time, will be recorded outside the system boundaries.

  • Proposed Analysis: Clinical Effectiveness Analysis: The clinical effectiveness outcome will be the time to extubation after ICU admission. This will allow a comparison of the clinical effectiveness of the enhanced recovery intervention with standard practice, assuming that ICU management is standardized for both interventions and that proactive measures aimed at early extubation and reduced ICU stay are routine.

Economic Analysis: The cost of the intervention will be updated and described, including marginal, incremental, and average costs. Direct costs will be estimated using micro-costing techniques. Direct healthcare costs associated with the health technologies used, such as medications, medical devices, and care provided by healthcare professionals, among others, will be measured and quantified. The labor cost of each professional participating in the interventions will be quantified by measuring the number of minutes each professional works. The costs of infrastructure use (electricity, water, heating, operating room time, operating room fees) used in each procedure will be determined as follows: Depreciation of equipment and infrastructure will not be included. The cost will have an operational focus.

Environmental Impact Analysis: The life-cycle assessment will be conducted in accordance with the methods established in ISO 14040 (2006a) and ISO 14044 (2006b). These will consider: The scope, which will encompass inputs from "cradle to grave", including those used to perform each anesthetic procedure from the moment the patient enters the operating room until they leave. The functional unit is an adult patient under anesthesia for 1 hour, weighing an average of 70 kg, and the reference flow will be the quantity of anesthetics and other supplies used during a myocardial revascularization surgery. The system boundaries encompass the extraction of raw materials, production, use, and end-of-life of the processes and products required for each type of anesthetic technique, from the moment the patient enters the operating room until they leave. Next, a life cycle inventory analysis will be conducted. Information and costs for each procedure will be obtained from the hospital's electronic records. Real-time data will be obtained on the quantities of medications used and waste generated, and the details of each component will be quantified. The impacts from waste transportation will be calculated based on distances from the hospital to the landfill and recycling facilities. Electricity consumption will be quantified directly in each operating room. An environmental impact study will be conducted using the CCALC database and OpenLCA software to estimate CO2e emissions. Finally, significant environmental flows and aspects (emissions, resources, waste, inputs, etc.) will be identified, along with the life-cycle stage at which they occur and the critical points. The resulting harm to human health, measured in DALYs, will also be estimated.

Sustainability Analysis: After establishing the clinical effectiveness of the intervention in terms of extubation times, the sustainability of each intervention will be evaluated by analyzing updated anesthesia costs for myocardial revascularization surgery and the critical environmental impacts per hour of anesthetized patient in the operating room (functional unit). This will yield an indicator expressed as costs in Euros/critical points of environmental damage (CO2e) per hour of an anesthetized patient in the operating room, using this as the average value of the ratio.

Being tested
Optimized recovery, Standard Anesthetic Practice
Keywords
sustainability, myocardial revascularization surgery, Enhanced recovery after surgery, life cycle assessment, cost effectiveness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized recoveryProcedure or surgery

    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).

  • Standard Anesthetic PracticeOther

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

Study groups in NCT07508865
Study groupRoleWhat they receive
Optimized recoveryA 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.
Receives: Procedure: Optimized recovery
Standard Anesthetic PracticeThe common practice or routine anesthetic practice
Receives: Other: Standard Anesthetic Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (3)
  1. Clinical effectiveness

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

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

  2. Environmental Impact Analysis

    Life Cycle Assessment results: The indicator is climate change, through impact categories such as CO2e, the analysis of which will determine the critical environmental impact points (CPs) resulting from the analytical work.

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

  3. Cost analysis

    For each intervention, the average cost per patient or per intervention and the incremental cost will be measured.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start2 Jul 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
116 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508865
Sponsor's protocol ID
EINR2024
Status last verified
Mar 2026
First submitted
23 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The full database will be accessible in the publication through a provided link.

Publications

  • Simon-Tillaux N, Martin GL, Hajage D, Scheifer C, Beydon M, Dechartres A, Tubach F. Conducting observational analyses with the target trial emulation approach: a methodological systematic review. BMJ Open. 2024 Nov 12;14(11):e086595. doi: 10.1136/bmjopen-2024-086595.

    PubMed 39532374
  • 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.

    PubMed 35987897
  • Grinberg D, Buzzi R, Pozzi M, Schweizer R, Capsal JF, Thinot B, Quyen Le M, Obadia JF, Cottinet PJ. Eco-audit of conventional heart surgery procedures. Eur J Cardiothorac Surg. 2021 Dec 1;60(6):1325-1331. doi: 10.1093/ejcts/ezab320.

    PubMed 34411226
  • 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

  • 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.

    PubMed 29851650
  • 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.

    PubMed 36002191
  • 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.

    PubMed 34251875
  • 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.

    PubMed 29072942
  • 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.

    PubMed 33159874
  • 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.

    PubMed 33307082
  • 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.

    PubMed 31116121

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Bypass and Anesthesia, run by Universidad de La Frontera at 1 site in Chile.

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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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 Chile. 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 Waldo Merino, MSc (+56974954831, waldo.merino@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustainability result (time frame: From the moment he enters the operating room until the endotracheal tube is removed in the ICU.). 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 NCT07508865, which also lists 11 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 2 Apr 2026.

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