AnesthesiaNCT04271462
The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia
An observational study of Anesthesia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Comparing two CO2 absorbers in the ventilator circuit
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Feb 2020to 29 May 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing general anesthesia with sevoflurane for > 2 hours.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
About this study
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.
Read more
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
- Being tested
- Comparing two CO2 absorbers in the ventilator circuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing two CO2 absorbers in the ventilator circuitOther
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):
- 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 | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing surgery (>120 min) with the use of sevoflurane based general anaesthesia (in 1.0 MAC concentration). Receives: Other: Comparing two CO2 absorbers in the ventilator circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of CO2 filters on Sevoflurane consumption
Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers
Measured: 30 minutes per filter
Secondary outcomes (1)
Influence of fresh gas flow on Sevoflurane consumption
Comparing Sevoflurane consumption between 0.5 and 2.0 liters per minute fresh gas flow
Measured: 30 minutes per fresh gas flow setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start12 Feb 2020
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niek Sperna Weiland, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271462
- Sponsor's protocol ID
- W20_025 # 20.051
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia
- ClinicalTrials.gov ID
- NCT04271462
- Acronym / sponsor ID
- W20_025 # 20.051
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Comparing two CO2 absorbers in the ventilator circuitPatients undergoing surgery (>120 min) with the use of sevoflurane based general anaesthesia (in 1.0 MAC concentration). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing general anesthesia with sevoflurane for > 2 hours.
Key inclusion criteria (6 listed)
- Adult patient
- non-pregnant
- ASA-I to ASA-III
- undergoing Sevoflurane based general anaesthesia (in a therapeutic concentration of 1.0 MAC)
- Elective surgery
Key exclusion criteria (7 listed)
- Unable/ unwilling to participate
- ASA-IV or higher
- Age < 18 years
- Known pregnancy
- Contra-indications for sevoflurane anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparing two CO2 absorbers in the ventilator circuitGeneral 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. | Other | Study group |
Primary outcome
Influence of CO2 filters on Sevoflurane consumption
Time frame: 30 minutes per filter
Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers
1 secondary outcome
Influence of fresh gas flow on Sevoflurane consumption
Time frame: 30 minutes per fresh gas flow setting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of CO2 filters on Sevoflurane consumption (time frame: 30 minutes per filter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.