Gas; InhalationCARINGNCT04163848
CARbon Impact of aNesthesic Gas
An observational study of Gas; Inhalation and Anesthesia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gas; Inhalation, Anesthesia
- What is being tested?
- Pollution
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2019to 23 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: General population undergoing laparoscopic gynecologic, urologic or general surgery
Who may be able to join
- ASA 1-3 patients,
- laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique
- fully consented,
- BMI < 40,
- age > 18yo,
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal, Quebec, H1T2M4
About this study
Official title: 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.
- Conditions
- Gas; Inhalation, Anesthesia
- Being tested
- Pollution
- Keywords
- Desflurane, Sevoflurane, Fresh gas flow, Environment
- Medical subject headings
- Mucopolysaccharidosis IV, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PollutionOther
CO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pollution | |
| 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 Receives: Other: Pollution |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO2 equivalent of volatile inhaled anesthesic gases use in grams
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
Measured: From intubation to end of surgery
Secondary outcomes (4)
Total volatile inhalated anesthesics consumption in mL
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
Measured: From intubation to end of surgery
Cost in dollars
To compare the total cost of volatile inhalated anesthesics (mL of gaz x $/mL of gaz) for each group
Measured: From intubation to end of surgery
Extubation time in minutes
To compare the extubation time
Measured: From stopping anesthesics gases to extubation
Recovery room time in minutes
To compare the time spent in the recovery room
Measured: From end of surgery to 240minutes post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start25 Sep 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gas; InhalationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Verdonck, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163848
- Sponsor's protocol ID
- 2020-1971
- Acronym
- CARING
- Status last verified
- Jan 2021
- First submitted
- 6 Nov 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARbon Impact of aNesthesic Gas - A Carbon Footprint Comparison of Sevoflurane and Desflurane in an Optimized Fresh Gas Flow Protocol
- ClinicalTrials.gov ID
- NCT04163848
- Acronym / sponsor ID
- CARING / 2020-1971
- Conditions
- Gas; Inhalation, Anesthesia
- Keywords
- Desflurane, Sevoflurane, Fresh gas flow, Environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | – | Other: Pollutiondesflurane 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 |
| Sevoflurane | – | Other: Pollutionsevoflurane 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population undergoing laparoscopic gynecologic, urologic or general surgery
Key inclusion criteria (5 listed)
- ASA 1-3 patients,
- laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique
- fully consented,
- BMI < 40,
- age > 18yo,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PollutionCO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery | Other | Desflurane, Sevoflurane |
Primary outcome
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
4 secondary outcomes
Total volatile inhalated anesthesics consumption in mL
Time frame: From intubation to end of surgery
Cost in dollars
Time frame: From intubation to end of surgery
Extubation time in minutes
Time frame: From stopping anesthesics gases to extubation
Recovery room time in minutes
Time frame: From end of surgery to 240minutes post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gas; Inhalation and Anesthesia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CO2 equivalent of volatile inhaled anesthesic gases use in grams (time frame: From intubation to end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.