ClinicalTrials.gg
CompletedNCT06602947Updated Sep 19, 2024

To Compare the Consumption of Sevoflurane and Desflurane in Low Flow Anaesthesia

An observational study in Sevoflurane and Desflurane, sponsored by Rajiv Gandhi Cancer Institute & Research Center, India. Completed at 1 site in India. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Rajiv Gandhi Cancer Institute & Research Center, India · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
564
Ages
20 Years to 65 Years
Sex
All
01

Study 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. 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

  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:

A. Carbon footprint calculation.

  1. Consumption of the anaesthetic agent will be recorded from the logbook Draeger Primus™ on termination of anaesthesia
  2. 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.
  3. 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.
  4. Estimation of carboxy haemoglobin (CoHb) levels as read from ABG analysis on termination of anaesthesia.
02

Conditions studied

  • Sevoflurane
  • Desflurane

Keywords

  • Low flow anesthesia
  • carbon footprint
03

In context

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with grade (ASA) I \& II.
  2. Patients with age 20-65 years.

Exclusion criteria

Exclusion Criteria:

  1. to inhalation agents.
  2. Liver dysfunction.
  3. Chronic alcoholism.
  4. Chronic smokers.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
564 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Other: Low flow anaesthesia using ASA enviormental sustanibility commitee recomendation

Interventions

  • OtherLow flow anaesthesia using ASA enviormental sustanibility commitee recomendation

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 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.

    Time frame: end of surgery

07

Study locations

1 site
  • RGCI& RC
    Delhi, 110085, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Sep 2021, 43 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2021
First posted
Sep 19, 2024
StartActual
Feb 16, 2018
Primary completionActual
Sep 16, 2021
CompletionActual
Dec 1, 2021
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06602947
Lead sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible party
Dr soumi pathak (Consultant Anaesthesia, Rajiv Gandhi Cancer Institute & Research Center, India) — Principal investigator
First posted
Sep 19, 2024
Start date
Feb 16, 2018
Primary completion
Sep 16, 2021
Completion
Dec 1, 2021
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion