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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271462
• Other study ID #: W20_025 # 20.051
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: May 29, 2020

Study information

• Verified date: February 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated CO2 footprint and environmental impact of general anaesthesia with two different CO2 filters	Estimate the CO2 footprint and environmental impact of general anaesthesia with sevoflurane comparing two different CO2 filters using life cycle analysis methods.	30 minutes
Other	Estimated cost of general anaesthesia with two different CO2 filters	Estimate the total cost of general anaesthesia with sevoflurane comparing two different CO2 filters using life cycle analysis methods.	30 minutes
Other	Estimated CO2 footprint and environmental impact of general anaesthesia with two fresh gas flow settings	Estimate the CO2 footprint of general anaesthesia with sevoflurane comparing two different fresh gas flow settings using life cycle analysis methods.	30 minutes
Other	Estimated cost of general anaesthesia with two fresh gas flow settings	Estimate the total cost of general anaesthesia with sevoflurane comparing two different fresh gas flow settings.	30 minutes
Primary	Influence of CO2 filters on Sevoflurane consumption	Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers	30 minutes per filter
Secondary	Influence of fresh gas flow on Sevoflurane consumption	Comparing Sevoflurane consumption between 0.5 and 2.0 liters per minute fresh gas flow	30 minutes per fresh gas flow setting