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

September 17, 2024 updated by: Dr soumi pathak, Rajiv Gandhi Cancer Institute & Research Center, India

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.

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

564

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Delhi, India, 110085
        • RGCI& RC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

Inclusion Criteria:

  1. Patients with American Society of Anesthesiologists grade (ASA) I & II.
  2. Patients with age 20-65 years.

Exclusion Criteria:

  1. Contraindications to inhalation agents.
  2. Liver dysfunction.
  3. Chronic alcoholism.
  4. Chronic smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
  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)

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.
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Duration of surgery 4hours,4-6 hours, more than 6hours
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
Duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To test whether significant generation of carbon monoxide occurs due to interaction of sevoflurane / desflurane with sodalime in the closed circuit.
end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2018

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Res/SCM/23/2017/53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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