AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

India1 site
  • RGCI& RC

    Delhi, 110085

Other trials in India

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

  1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
  2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
  3. 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

  1. Induction: Set the Vaporizer to Deliver a Concentration Greater than Intended
  2. Intubation: Turn Off the Fresh Gas Flow, Not the Vaporizer.
  3. 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:

  1. Carbon footprint calculation.
  2. Consumption of the anaesthetic agent will be recorded from the logbook Draeger Primus™ on termination of anaesthesia
  3. 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.
  4. 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.
  5. Estimation of carboxy haemoglobin (CoHb) levels as read from ABG analysis on termination of anaesthesia.
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

    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.
Study groups in NCT06602947
Study groupRoleWhat 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.

  1. 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

  2. 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)
  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.

  1. First posted19 Sep 2024
  2. Study start16 Feb 2018
  3. Primary completion16 Sep 2021
  4. Study completion1 Dec 2021

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in