SevofluraneNCT06602947
To Compare the Consumption of Sevoflurane and Desflurane in Low Flow Anaesthesia
An observational study of Sevoflurane and Desflurane, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
This prospective observational study aims to compare sevoflurane and Desflurane consumption in low-flow anaesthesia using the ASA (American Society of Anaesthesiology). Environmental Sustainability Committee recommendations. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sevoflurane, Desflurane
- What is being tested?
- Low flow anaesthesia using ASA enviormental sustanibility commitee recomendation
- How many people
- 564 participants
- Where
- 1 siteIndia
- Study dates
- 16 Feb 2018to 1 Dec 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 564 patients aged 20-65 and ASA status I-II scheduled for procedures longer than three hours duration at RGCI\&RC from 2017-2018 will be included in this study
Who may be able to join
- Patients with American Society of Anesthesiologists grade (ASA) I \& II.
- Patients with age 20-65 years.
Who cannot join
- Contraindications to inhalation agents.
- Liver dysfunction.
- Chronic alcoholism.
- Chronic smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Consumption of Sevoflurane and Desflurane in Low-flow Anesthesia Using the Recommendations of ASA (American Society of Anaesthesiologist Environmental Sustainability Committee
This prospective observational study aims to compare sevoflurane and Desflurane consumption in low-flow anaesthesia using the ASA (American Society of Anaesthesiology).
Environmental Sustainability Committee recommendations. The patients aged 20-65 years, ASA I and II undergoing surgery under general anaesthesia were included in the study.
Read more
Question: Can we reduce our carbon footprint of desflurane and sevoflurane using low-flow anaesthesia, according to the recommendations of the ASA Environment Sustainability Committee?
PRIMARY To compare the mac hour consumption of sevoflurane and desflurane anaesthetic agents under low flow (one litre/min) conditions To calculate the carbon footprint of sevoflurane and desflurane in the study cases.
SECONDARY To test whether a significant generation of carbon monoxide occurs due to the interaction of sevoflurane/desflurane with soda lime in the closed circuit Groups 1) low-flow sevoflurane (LFS)- 1 L/min gas flow 2) low- flow desflurane (LFD)- 1 L/min gas flow Anaesthesia will be administered according to the recommendations of the ASA Environment Sustainability Committee.
Three strategies to reduce the fresh gas flow and environmental contamination are
- Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
- Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
- Maintenance: Minimize Fresh Gas Flow During Maintenance.
Read the detailed description
OBJECTIVES
PRIMARY To compare the mac hour consumption of sevoflurane and desflurane anaesthetic agents under low flow (one litre/min) conditions To calculate the carbon footprint of sevoflurane and desflurane in the low-flow anaesthesia being used in this study
SECONDARY To test whether a significant generation of carbon monoxide occurs due to the interaction of sevoflurane/desflurane with soda lime in the closed circuit.
Methodology Two groups: 1) low-flow sevoflurane (LFS) 2) low- flow desflurane (LFD) Anaesthesia will be administered according to the recommendations of the ASA Environment Sustainability Committee.
Three strategies to reduce the fresh gas flow and environmental contamination are
- Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
- Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
- Maintenance: Minimize Fresh Gas Flow During Maintenance.
Five hundred sixty-four patients aged 20-65 and ASA status I-II scheduled for procedures longer than three hours duration at Rajiv Gandhi Cancer Institute \& Research Center (RGCI\&RC) from 2017-2018 will be included in this study.
Patients having severe cardiac and hepatic problems, renal dysfunction and chronic alcoholism are excluded from the study Computer-generated randomisation will be done to allocate the patients into two equal groups for low-flow sevoflurane and low-flow desflurane anaesthesia.
After the arrival of the patients, aVenous cannula will be inserted; midazolam 0.05 mg. kg-1 will be administered intravenously for anxiolysis. Noninvasive monitors, including electrocardiograms, non-invasive blood pressure monitoring, pulse oximetry, axillary temperature, and bispectral index (BIS), will be applied.
Anaesthesia will be induced with fentanyl (2µg.kg-1 ), propofol (2.5 mg. kg-1 ) and atracurium (0.5mg. kg -1 ) to facilitate endotracheal intubation.
All patients will be mechanically ventilated with a mixture of air-oxygen (50% oxygen + 50% air) in addition to the anaesthetic agent according to the study group using the anaesthesia workstation (Primus®, Dräger, Luebeck, Germany).
The tidal volume will be set at 8mL/kg, and the respiratory frequency will be to maintain an end-tidal CO 2 (Et CO2 ) between 30-35mmHg.
After intubation, anaesthesia will be maintained with the fresh gas flow (FRF) of 4 lit./min and 4% Vol sevoflurane or 6% Vol desflurane in the 50% oxygen/air mixture for 5 minutes.
The fresh gas flow will be decreased to 1 L min-1, and after that, dial concentration will be reduced by 0.5% every 2 minutes to maintain 1 MAC(minimum alveolar concentration).
The dial concentration after that will be adjusted to achieve a value of 1 MAC. An adequate neuromuscular blockade will be achieved by administering atracurium boluses of 0.1mg. kg-1 every 20min.
During skin closure, the anaesthetic will be discontinued, and the patient will receive 100% O 2.
At 25% recovery of the first response to train-of-four stimulation, the neuromuscular blockade will be reversed by neostigmine (4µg.kg-1 ) and atropine (15µg.kg-1 ). ABG( Arterial blood gas) were done baseline and post-procedure.
PARAMETERS TO BE RECORDED:
- Carbon footprint calculation.
- Consumption of the anaesthetic agent will be recorded from the logbook Draeger Primus™ on termination of anaesthesia
- Consumed inhalational agent (ml) in 1 MAC hour. Consumption of the inhalational agent (ml) will be converted to MAC hour consumption by dividing it by the entire duration of 1.0 MAC anaesthesia.
- Calculation of carbon dioxide equivalent. The consumed inhalational agent (ml) will be converted to tones by volume weight conversion formula (1.465 for Desflurane and 1.522 for Sevoflurane) and then multiplied by( Global warming potential) GWP100 (2540 for Desflurane and 130 for Sevoflurane) to get carbon dioxide equivalent.
- Estimation of carboxy haemoglobin (CoHb) levels as read from ABG analysis on termination of anaesthesia.
- Conditions
- Sevoflurane, Desflurane
- Being tested
- Low flow anaesthesia using ASA enviormental sustanibility commitee recomendation
- Keywords
- Low flow anesthesia, carbon footprint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow anaesthesia using ASA enviormental sustanibility commitee recomendationOther
- Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
- Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
- Maintanance: Minimize Fresh Gas Flow During Maintenance.
| Study group | Role | What they receive |
|---|---|---|
| low-flow sevoflurane (LFS) | Anaesthesia will be administered according to the recommendations of ASA Enviornment Sustainability Committee.
Three strategies to reduce the fresh gas flow and enviornmental contamination are
1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
3. Maintanance: Minimize Fresh Gas Flow During Maintenance. Receives: Other: Low flow anaesthesia using ASA enviormental sustanibility commitee recomendation | |
| low- flow desflurane (LFD) | Anaesthesia will be administered according to the recommendations of ASA Enviornment Sustainability Committee.
Three strategies to reduce the fresh gas flow and enviornmental contamination are
1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
3. Maintanance: Minimize Fresh Gas Flow During Maintenance. Receives: Other: Low flow anaesthesia using ASA enviormental sustanibility commitee recomendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the MAC hour consumption of sevoflurane under low flow conditions. To compare the mac hour consumption of sevoflurane and desflurane anasthetic agents under low flow (one litre/min) conditi
To compare the mac hour consumption of sevoflurane anasthetic agents under low flow (one litre/min) conditions To calculate the carbon foot print of sevoflurane and desflurane in the low flow anaesthesia being used in this study
Measured: Duration of surgery 4hours,4-6 hours, more than 6hours
To calculate the carbon foot print of sevoflurane and desflurane in low flow anaesthesia
Carbon foot print calculation according to the formula
Measured: Duration of surgery
Secondary outcomes (1)
To test whether significant generation of carbon monoxide occurs due to interaction of sevoflurane / desflurane with sodalime in the closed circuit.
To test whether significant generation of carbon monoxide occurs due to interaction of sevoflurane / desflurane with sodalime in the closed circuit.
Measured: end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Feb 2018
- Primary completion16 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr soumi pathak, Rajiv Gandhi Cancer Institute & Research Center, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602947
- Sponsor's protocol ID
- Res/SCM/23/2017/53
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Consumption of Sevoflurane and Desflurane in Low-flow Anesthesia Using the Recommendations of ASA (American Society of Anaesthesiologist Environmental Sustainability Committee
- ClinicalTrials.gov ID
- NCT06602947
- Acronym / sponsor ID
- Res/SCM/23/2017/53
- Conditions
- Sevoflurane, Desflurane
- Keywords
- Low flow anesthesia, carbon footprint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Sep 2024 (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.
This prospective observational study aims to compare sevoflurane and Desflurane consumption in low-flow anaesthesia using the ASA (American Society of Anaesthesiology).
Environmental Sustainability Committee recommendations. The patients aged 20-65 years, ASA I and II undergoing surgery under general anaesthesia were included in the study.
Question: Can we reduce our carbon footprint of desflurane and sevoflurane using low-flow anaesthesia, according to the recommendations of the ASA Environment Sustainability Committee?
PRIMARY To compare the mac hour consumption of sevoflurane and desflurane anaesthetic agents under low flow (one litre/min) conditions To calculate the carbon footprint of sevoflurane and desflurane in the study cases.
SECONDARY To test whether a significant generation of carbon monoxide occurs due to the interaction of sevoflurane/desflurane with soda lime in the closed circuit Groups 1) low-flow sevoflurane (LFS)- 1 L/min gas flow 2) low- flow desflurane (LFD)- 1 L/min gas flow Anaesthesia will be administered according to the recommendations of the ASA Environment Sustainability Committee.
Three strategies to reduce the fresh gas flow and environmental contamination are
- Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
- Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
- Maintenance: Minimize Fresh Gas Flow During Maintenance.
Detailed description
OBJECTIVES
PRIMARY To compare the mac hour consumption of sevoflurane and desflurane anaesthetic agents under low flow (one litre/min) conditions To calculate the carbon footprint of sevoflurane and desflurane in the low-flow anaesthesia being used in this study
SECONDARY To test whether a significant generation of carbon monoxide occurs due to the interaction of sevoflurane/desflurane with soda lime in the closed circuit.
Methodology Two groups: 1) low-flow sevoflurane (LFS) 2) low- flow desflurane (LFD) Anaesthesia will be administered according to the recommendations of the ASA Environment Sustainability Committee.
Three strategies to reduce the fresh gas flow and environmental contamination are
- Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
- Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
- Maintenance: Minimize Fresh Gas Flow During Maintenance.
Five hundred sixty-four patients aged 20-65 and ASA status I-II scheduled for procedures longer than three hours duration at Rajiv Gandhi Cancer Institute \& Research Center (RGCI\&RC) from 2017-2018 will be included in this study.
Patients having severe cardiac and hepatic problems, renal dysfunction and chronic alcoholism are excluded from the study Computer-generated randomisation will be done to allocate the patients into two equal groups for low-flow sevoflurane and low-flow desflurane anaesthesia.
After the arrival of the patients, aVenous cannula will be inserted; midazolam 0.05 mg. kg-1 will be administered intravenously for anxiolysis. Noninvasive monitors, including electrocardiograms, non-invasive blood pressure monitoring, pulse oximetry, axillary temperature, and bispectral index (BIS), will be applied.
Anaesthesia will be induced with fentanyl (2µg.kg-1 ), propofol (2.5 mg. kg-1 ) and atracurium (0.5mg. kg -1 ) to facilitate endotracheal intubation.
All patients will be mechanically ventilated with a mixture of air-oxygen (50% oxygen + 50% air) in addition to the anaesthetic agent according to the study group using the anaesthesia workstation (Primus®, Dräger, Luebeck, Germany).
The tidal volume will be set at 8mL/kg, and the respiratory frequency will be to maintain an end-tidal CO 2 (Et CO2 ) between 30-35mmHg.
After intubation, anaesthesia will be maintained with the fresh gas flow (FRF) of 4 lit./min and 4% Vol sevoflurane or 6% Vol desflurane in the 50% oxygen/air mixture for 5 minutes.
The fresh gas flow will be decreased to 1 L min-1, and after that, dial concentration will be reduced by 0.5% every 2 minutes to maintain 1 MAC(minimum alveolar concentration).
The dial concentration after that will be adjusted to achieve a value of 1 MAC. An adequate neuromuscular blockade will be achieved by administering atracurium boluses of 0.1mg. kg-1 every 20min.
During skin closure, the anaesthetic will be discontinued, and the patient will receive 100% O 2.
At 25% recovery of the first response to train-of-four stimulation, the neuromuscular blockade will be reversed by neostigmine (4µg.kg-1 ) and atropine (15µg.kg-1 ). ABG( Arterial blood gas) were done baseline and post-procedure.
PARAMETERS TO BE RECORDED:
- Carbon footprint calculation.
- Consumption of the anaesthetic agent will be recorded from the logbook Draeger Primus™ on termination of anaesthesia
- Consumed inhalational agent (ml) in 1 MAC hour. Consumption of the inhalational agent (ml) will be converted to MAC hour consumption by dividing it by the entire duration of 1.0 MAC anaesthesia.
- Calculation of carbon dioxide equivalent. The consumed inhalational agent (ml) will be converted to tones by volume weight conversion formula (1.465 for Desflurane and 1.522 for Sevoflurane) and then multiplied by( Global warming potential) GWP100 (2540 for Desflurane and 130 for Sevoflurane) to get carbon dioxide equivalent.
- Estimation of carboxy haemoglobin (CoHb) levels as read from ABG analysis on termination of anaesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-flow sevoflurane (LFS) | – | Other: Low flow anaesthesia using ASA enviormental sustanibility commitee recomendationAnaesthesia will be administered according to the recommendations of ASA Enviornment Sustainability Committee. Three strategies to reduce the fresh gas flow and enviornmental contamination are 1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended 2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer. 3. Maintanance: Minimize Fresh Gas Flow During Maintenance. |
| low- flow desflurane (LFD) | – | Other: Low flow anaesthesia using ASA enviormental sustanibility commitee recomendationAnaesthesia will be administered according to the recommendations of ASA Enviornment Sustainability Committee. Three strategies to reduce the fresh gas flow and enviornmental contamination are 1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended 2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer. 3. Maintanance: Minimize Fresh Gas Flow During Maintenance. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 564 patients aged 20-65 and ASA status I-II scheduled for procedures longer than three hours duration at RGCI\&RC from 2017-2018 will be included in this study
Key inclusion criteria (2 listed)
- Patients with American Society of Anesthesiologists grade (ASA) I \& II.
- Patients with age 20-65 years.
Key exclusion criteria (4 listed)
- Contraindications to inhalation agents.
- Liver dysfunction.
- Chronic alcoholism.
- Chronic smokers.
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 |
|---|---|---|
| Low flow anaesthesia using ASA enviormental sustanibility commitee recomendation1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended 2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer. 3. Maintanance: Minimize Fresh Gas Flow During Maintenance. | Other | low- flow desflurane (LFD), low-flow sevoflurane (LFS) |
Primary outcome
To compare the MAC hour consumption of sevoflurane under low flow conditions. To compare the mac hour consumption of sevoflurane and desflurane anasthetic agents under low flow (one litre/min) conditi
Time frame: Duration of surgery 4hours,4-6 hours, more than 6hours
To compare the mac hour consumption of sevoflurane anasthetic agents under low flow (one litre/min) conditions To calculate the carbon foot print of sevoflurane and desflurane in the low flow anaesthesia being used in this study
To calculate the carbon foot print of sevoflurane and desflurane in low flow anaesthesia
Time frame: Duration of surgery
Carbon foot print calculation according to the formula
1 secondary outcome
To test whether significant generation of carbon monoxide occurs due to interaction of sevoflurane / desflurane with sodalime in the closed circuit.
Time frame: end of surgery
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 19 Sep 2024.
- 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 Sevoflurane and Desflurane, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 2 inclusion and 4 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 19 Sep 2024. 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 India. 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?
To compare the MAC hour consumption of sevoflurane under low flow conditions. To compare the mac hour consumption of sevoflurane and desflurane anasthetic agents under low flow (one litre/min) conditi (time frame: Duration of surgery 4hours,4-6 hours, more than 6hours). The study lists 2 primary outcomes in all. 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 19 Sep 2024.