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Completed

NCT Number: NCT04271462

The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia

Traditional sodalime CO2 absorbers are known to not only react with CO2 but also with sevoflurane. Therewith, a potentially harmful compound (compound A) is formed that can be nephrotoxic. In the United States, the sevoflurane manufacturer therefore recommends keeping the FGF (FGF) at >2.0 L min-1 if a sodalime CO2 absorbent is used. Amsorb Plus® (Datex-Ohmeda Inc., Madison, WI, USA), is a novel type of CO2 absorbent that does not react with sevoflurane. This allows the FGF to be reduced to 0.5 L min-1. This has two important advantages: (i) less fresh sevoflurane is added to the circle system, and (ii) the sevoflurane that is in the system does not react with the CO2 absorber.

Sevoflurane is a potent greenhouse gas with a 100 year CO2-equivalents of 120. Measures that can reduce the consumption of volatile anaesthetics could make a significant contribution to reducing the carbon footprint of the operative process. Additionally, Amsorb Plus® canisters seem to have a longer life span than sodalime canisters and do not need to be disposed of via toxic waste stream, but via domestic waste.

In this study, we were interested if (i) the use of Amsorb Plus leads to a reduction in sevoflurane usage and therefore contribute to a reduction in the CO2 footprint of general anaesthesia with sevoflurane, (ii) Does the use of Amsorb Plus® lead to a reduction in the amount of (toxic) waste produced by operating theatres?

Comparator: a traditional sodalime CO2 absorber (Medisorb™ Multi-Absorber Original, CareFusion, Helsinki, Finland).

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Key information

Conditions

Anesthesia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient
  • non-pregnant
  • ASA-I to ASA-III
  • undergoing Sevoflurane based general anaesthesia (in a therapeutic concentration of 1.0 MAC)
  • Elective surgery
  • Scheduled operating time >2 hours.

Exclusion criteria

  • Unable/ unwilling to participate
  • ASA-IV or higher
  • Age < 18 years
  • Known pregnancy
  • Contra-indications for sevoflurane anaesthesia
  • Emergency surgery
  • Scheduled operating time <2 hours.

Treatment and study plan

Comparing two CO2 absorbers in the ventilator circuit

Other

General anaesthesia will be induced with a standardised regimen (propofol 0.8-2.5 mg·kg-1, sufentanil 0.2 - 0.5 µg·kg-1 and rocuronium 0.5 - 1 mg·kg-1). After tracheal intubation, anaesthesia will be maintained with sevoflurane targeted at 1 MAC end tidal concentration (corrected for age using the formula by Mapleson) in 40% O2. Different ventilator settings will be compared for 30 minutes (in randomised order):

I. Sodalime, FGF 2.0 L min-1. II. Amsorb Plus®, FGF 2.0 L min-1. III. Soda lime, FGF, 0.5 L min-1. IV. Amsorb Plus®, FGF 0.5 L min-1. FGF=fresh gas flow.

Primary outcomes

  1. Influence of CO2 filters on Sevoflurane consumption

    Time frame: 30 minutes per filter

    Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers

Secondary outcomes

  1. Influence of fresh gas flow on Sevoflurane consumption

    Time frame: 30 minutes per fresh gas flow setting

    Comparing Sevoflurane consumption between 0.5 and 2.0 liters per minute fresh gas flow

Other outcomes

  1. Estimated CO2 footprint and environmental impact of general anaesthesia with two different CO2 filters

    Time frame: 30 minutes

    Estimate the CO2 footprint and environmental impact of general anaesthesia with sevoflurane comparing two different CO2 filters using life cycle analysis methods.

  2. Estimated cost of general anaesthesia with two different CO2 filters

    Time frame: 30 minutes

    Estimate the total cost of general anaesthesia with sevoflurane comparing two different CO2 filters using life cycle analysis methods.

  3. Estimated CO2 footprint and environmental impact of general anaesthesia with two fresh gas flow settings

    Time frame: 30 minutes

    Estimate the CO2 footprint of general anaesthesia with sevoflurane comparing two different fresh gas flow settings using life cycle analysis methods.

  4. Estimated cost of general anaesthesia with two fresh gas flow settings

    Time frame: 30 minutes

    Estimate the total cost of general anaesthesia with sevoflurane comparing two different fresh gas flow settings.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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