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

NCT04271462 | Completed

• 1 other identifier: W20_025 # 20.051
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Influence of CO2 filters on Sevoflurane consumption

  Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers

  30 minutes per filter

Secondary Outcomes (1)

• Influence of fresh gas flow on Sevoflurane consumption

  30 minutes per fresh gas flow setting

Other Outcomes (4)

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

  30 minutes

• Estimated cost of general anaesthesia with two different CO2 filters

  30 minutes

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

  30 minutes

Study Arms (1)

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

Interventions

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.

Study group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing general anesthesia with sevoflurane for \> 2 hours.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anaesthesiologist (MD PhD)

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 12, 2020
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)