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

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ClinicalTrials.gov Identifier: NCT04271462
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Niek Sperna Weiland, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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).


Condition or disease Intervention/treatment
Anesthesia Other: Comparing two CO2 absorbers in the ventilator circuit

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 38 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study group
Patients undergoing surgery (>120 min) with the use of sevoflurane based general anaesthesia (in 1.0 MAC concentration).
Other: Comparing two CO2 absorbers in the ventilator circuit

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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing general anesthesia with sevoflurane for > 2 hours.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271462


Contacts
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Contact: Niek Sperna Weiland, MD PhD 020-5669111 N.H.SpernaWeiland@amsterdamumc.nl

Locations
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Netherlands
Amsterdam UMC, location AMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Jeroen Hermanides, MD PhD    +31 20 5669111    j.hermanides@amc.uva.nl   
Sub-Investigator: Niek Sperna Weiland, MD PhD         
Sub-Investigator: Jante Sinnige, BSc         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Niek Sperna Weiland, Staff Anaesthesiologist (MD PhD), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04271462    
Other Study ID Numbers: W20_025 # 20.051
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No