- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07313969
Ultra-Low-Flow Anesthesia and Carbon Footprint
The Impact of Ultra-Low-Flow Sevoflurane Anesthesia on Carbon Footprint and Cost: A Randomized Controlled Study in Cardiac Surgery Patients
This is a prospective, randomized controlled clinical trial evaluating the effects of ultra-low fresh gas flow (0.5 L/min) versus normal fresh gas flow (2.0 L/min) sevoflurane anesthesia in adult patients undergoing on-pump cardiac surgery. The study aims to determine whether ultra-low-flow anesthesia can be used safely to reduce volatile anesthetic consumption and environmental emissions without compromising hemodynamic stability or anesthetic depth.
Eligible adult patients scheduled for elective coronary artery bypass grafting (CABG) or valve surgery under general anesthesia will be randomized in a 1:1 ratio to one of two groups: ultra-low-flow (0.5 L/min) or normal-flow (2.0 L/min). All other anesthetic techniques, including induction drugs, ventilation parameters, temperature management, and perfusion strategies, will be standardized.
The primary outcome is the total amount of sevoflurane consumed per case. Secondary outcomes include intraoperative hemodynamic parameters (heart rate, mean arterial pressure), depth of anesthesia (BIS/MAC values), postoperative recovery times, and estimated carbon dioxide equivalent (CO₂e) emissions.
Outcome assessors and data analysts will remain blinded to group allocation. The findings of this study are expected to provide new evidence regarding the safety, efficiency, and environmental benefits of ultra-low-flow anesthesia techniques in cardiac surgery.
Study Overview
Status
Intervention / Treatment
Detailed Description
This randomized controlled trial investigates the impact of ultra-low-flow (0.5 L/min) versus normal-flow (2.0 L/min) sevoflurane anesthesia on anesthetic consumption, intraoperative hemodynamics, and environmental footprint during on-pump cardiac surgery. Although low-flow anesthesia is known to reduce anesthetic agent use and greenhouse gas emissions, evidence regarding its safety and efficiency during cardiopulmonary bypass procedures remains limited.
Adult patients scheduled for elective CABG or valve surgery will be randomly assigned to either an ultra-low-flow or normal-flow group. Randomization will be performed using a computer-generated sequence with variable block sizes and allocation concealment via sequentially numbered, opaque, sealed envelopes. All participants will receive standardized induction, perfusion, and maintenance techniques according to institutional cardiac anesthesia protocols.
The primary outcome measure is total sevoflurane consumption per patient, assessed through vaporizer readings and anesthetic gas analyzer data. Secondary outcomes include intraoperative mean arterial pressure, heart rate, BIS/MAC values, body temperature, recovery characteristics, and calculated CO₂ equivalent emissions. Outcome assessors and data analysts will remain blinded to group allocation.
This study is designed to evaluate both clinical and ecological aspects of anesthetic practice. It aims to determine whether ultra-low-flow anesthesia can provide equivalent anesthetic quality while offering substantial reductions in agent consumption and environmental impact. The findings may contribute to establishing safer and more sustainable anesthesia standards for cardiac surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06810
- Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18-80 years
- Scheduled for elective on-pump CABG or valve surgery
- ASA physical status II-III
- Written informed consent obtained
Exclusion Criteria:
- Emergency surgery
- Severe hepatic or renal dysfunction
- Known allergy to volatile anesthetics
- Significant pulmonary disease (e.g., COPD with GOLD III-IV)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultra-Low-Flow Group (0.5 L/min)
Sevoflurane anesthesia with fresh gas flow maintained at 0.5 L/min throughout the maintenance period. A 2 lt/min fresh gas flow will be used in the preoxygenation and intubation phase. General anesthesia will be maintained with sevoflurane at a fresh gas flow rate of 0.5 L/min using an oxygen and air mixture. The flow rate will be kept constant from post-induction stabilization until the end of the surgery. Ventilation will be paused during cardiopulmonary bypass. |
General anesthesia will be maintained with sevoflurane at a fresh gas flow rate of 0.5 L/min using oxygen and air mixture.
The flow rate will be kept constant from post-induction stabilization until the end of cardiopulmonary bypass.
|
|
Active Comparator: Normal-Flow Group (2.0 L/min)
Sevoflurane anesthesia with fresh gas flow maintained at 2.0 L/min throughout maintenance period.
The flow rate will be kept constant from post-induction stabilization until the end of surgery.
Ventilation will be paused during cardiopulmonary bypass
|
General anesthesia will be maintained with sevoflurane at a fresh gas flow rate of 2.0 L/min using oxygen and air mixture.
The flow rate will be kept constant from post-induction stabilization until the end of cardiopulmonary bypass.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total sevoflurane consumption (mL per case), measured at the end of surgery.
Time Frame: throughout the surgery
|
throughout the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
carbon footprint
Time Frame: throughout the surgery
|
Estimated CO₂e emissions (calculated from anesthetic use)
|
throughout the surgery
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Ultra_low_flow
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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