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

February 10, 2021 updated by: Niek Sperna Weiland, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38

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

    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, location AMC

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing general anesthesia with sevoflurane for > 2 hours.

Description

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.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients undergoing surgery (>120 min) with the use of sevoflurane based general anaesthesia (in 1.0 MAC concentration).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of CO2 filters on Sevoflurane consumption
Time Frame: 30 minutes per filter
Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers
30 minutes per filter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes per fresh gas flow setting

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes
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.
30 minutes
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.
30 minutes
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.
30 minutes

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)

February 12, 2020

Primary Completion (Actual)

May 29, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • W20_025 # 20.051

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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