- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163848
CARbon Impact of aNesthesic Gas (CARING)
January 26, 2021 updated by: Olivier Verdonck, Ciusss de L'Est de l'Île de Montréal
CARbon Impact of aNesthesic Gas - A Carbon Footprint Comparison of Sevoflurane and Desflurane in an Optimized Fresh Gas Flow Protocol
Assessing the impact of anesthesia practice on global warming and carbon footprint becomes part of the standard of care and is growing concern within the anesthesia community.
Global Warming Potential (GWP) is a measure of how much a given mass of greenhouse gas contributes to global warming over a specified time period.
Inhaled anesthetics have various GWP20: 349 for sevoflurane and 3714 for desflurane.
However, GWP20 and CDE20 alone are not sufficient to evaluate the environmental impact of anesthetic gases.
Other parameters must be included in the analysis: fresh gas flow (FGF), carrier gas (air, O2, N2O) and potency of the anesthetic gas.
Unfortunately, the majority of trials did not fully consider the FGF reduction and the fact that desflurane can be administered with new closed or very low-flow anesthesia circuits as opposed as the recommended 2L/min that must be used for sevoflurane according to its monography in Canada.
Most of the calculations were made on a purely theoretical approach that could be different from actual measurements based on a strictly monitored anesthesia practice.
When continuous and accurate gas monitoring and analysis is used as recommended nowadays, the use of closed or semi-closed-circuit anesthesia with very low FGF might allow for a reduction of more than 80% of the anesthetic gas administration and its consequent pollution.
By properly monitoring the anesthesia depth and analgesia adequacy, the investigators can reduce the gas consumption.
The proposed study will aim at determining whether with the help of high-quality monitoring (BIS and NOL) and high-end ventilators that allow minimal fresh gas flow, the use of desflurane remains more polluting than sevoflurane.
Study Overview
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H1T2M4
- Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
General population undergoing laparoscopic gynecologic, urologic or general surgery
Description
Inclusion Criteria:
- ASA 1-3 patients,
- laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique
- fully consented,
- BMI < 40,
- age > 18yo,
Exclusion Criteria:
- post-operative need for a neuraxial or regional analgesic technique
- history of active coronary artery disease
- serious cardiac arrhythmia (including atrial fibrillation)
- history of substance abuse
- chronic use of psychotropic and/or opioid drugs
- history of psychiatric diseases with the need of medication
- history of refractory PONV
- allergy or contra-indication to any drug used in the study protocol
- refusal of the patient for participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Desflurane
desflurane administration based on a BIS index kept between 40-60 and with use of the semi-closed circuit of the Draeger A500 ventilator and its econometer for an optimized fresh gas flow as low as the O2 consumption allows
|
CO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery
|
Sevoflurane
sevoflurane administration based on a BIS kept between 40-60 and with use of the semi-closed circuit of the Draeger A500 ventilator with a fixed fresh gas flow of 2L/min as requested in the gas monography
|
CO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CO2 equivalent of volatile inhaled anesthesic gases use in grams
Time Frame: From intubation to end of surgery
|
To compare total volatile inhaled anesthetics consumption in CO2 equivalent (grams) per hour during anesthesia for laparoscopic surgery between two groups: Group "D" for Desflurane and group "S" for Sevoflurane
|
From intubation to end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total volatile inhalated anesthesics consumption in mL
Time Frame: From intubation to end of surgery
|
To compare the total volatile inhaled anesthetics consumption in mL, mL/h and mL/kg/h during anesthesia for laparoscopic surgery between desflurane and sevoflurane
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From intubation to end of surgery
|
Cost in dollars
Time Frame: From intubation to end of surgery
|
To compare the total cost of volatile inhalated anesthesics (mL of gaz x $/mL of gaz) for each group
|
From intubation to end of surgery
|
Extubation time in minutes
Time Frame: From stopping anesthesics gases to extubation
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To compare the extubation time
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From stopping anesthesics gases to extubation
|
Recovery room time in minutes
Time Frame: From end of surgery to 240minutes post-surgery
|
To compare the time spent in the recovery room
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From end of surgery to 240minutes post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 25, 2019
Primary Completion (ACTUAL)
January 23, 2020
Study Completion (ACTUAL)
January 23, 2020
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 12, 2019
First Posted (ACTUAL)
November 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1971
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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