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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Canada
    • Quebec
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Pollution
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
Other: Pollution
CO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
To compare the extubation time
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
From end of surgery to 240minutes post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ciusss de L'Est de l'Île de Montréal

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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