Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:35 PM
Study NCT ID:
NCT07313969
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra-Low-Flow Anesthesia and Carbon Footprint
Sponsor:
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Organization:
Study Overview
Official Title:
The Impact of Ultra-Low-Flow Sevoflurane Anesthesia on Carbon Footprint and Cost: A Randomized Controlled Study in Cardiac Surgery Patients
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: