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

NCT ID: NCT04271462

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2020-05-29

Brief Summary

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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).

Detailed Description

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Conditions

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Anesthesia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Patients undergoing surgery (\>120 min) with the use of sevoflurane based general anaesthesia (in 1.0 MAC concentration).

Comparing two CO2 absorbers in the ventilator circuit

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Niek Sperna Weiland

Staff Anaesthesiologist (MD PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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W20_025 # 20.051

Identifier Type: -

Identifier Source: org_study_id

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