- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271462
The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
- Amsterdam UMC, location AMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group
Patients undergoing surgery (>120 min) with the use of sevoflurane based general anaesthesia (in 1.0 MAC concentration).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of CO2 filters on Sevoflurane consumption
Time Frame: 30 minutes per filter
|
Comparing Sevoflurane consumption between Amsorb Plus and sodalime CO2 absorbers
|
30 minutes per filter
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes per fresh gas flow setting
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 minutes
|
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.
|
30 minutes
|
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.
|
30 minutes
|
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.
|
30 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- W20_025 # 20.051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
University of ChicagoRecruitingAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMNot yet recruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Matthew BorzageRecruitingAnesthesia | Anesthesia; ReactionUnited States