Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602947
Status:
COMPLETED
Last Update Posted:
None
First Post:
2021-09-19
Brief Title:
To Compare the Consumption of Sevoflurane and Desflurane in Low Flow Anaesthesia
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 litremin 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 sevofluranedesflurane with soda lime in the closed circuit Groups 1 low-flow sevoflurane LFS- 1 Lmin gas flow 2 low- flow desflurane LFD- 1 Lmin 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
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 litremin 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 sevofluranedesflurane with soda lime in the closed circuit Groups 1 low-flow sevoflurane LFS- 1 Lmin gas flow 2 low- flow desflurane LFD- 1 Lmin 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
Detailed Description:
OBJECTIVES
PRIMARY To compare the mac hour consumption of sevoflurane and desflurane anaesthetic agents under low flow one litremin 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 sevofluranedesflurane 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 RGCIRC 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 005 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 2µgkg-1 propofol 25 mg kg-1 and atracurium 05mg 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 8mLkg 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 litmin and 4 Vol sevoflurane or 6 Vol desflurane in the 50 oxygenair 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 05 every 2 minutes to maintain 1 MACminimum 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 01mg 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 4µgkg-1 and atropine 15µgkg-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 10 MAC anaesthesia
3 Calculation of carbon dioxide equivalent The consumed inhalational agent ml will be converted to tones by volume weight conversion formula 1465 for Desflurane and 1522 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
PRIMARY To compare the mac hour consumption of sevoflurane and desflurane anaesthetic agents under low flow one litremin 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 sevofluranedesflurane 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 RGCIRC 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 005 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 2µgkg-1 propofol 25 mg kg-1 and atracurium 05mg 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 8mLkg 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 litmin and 4 Vol sevoflurane or 6 Vol desflurane in the 50 oxygenair 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 05 every 2 minutes to maintain 1 MACminimum 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 01mg 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 4µgkg-1 and atropine 15µgkg-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 10 MAC anaesthesia
3 Calculation of carbon dioxide equivalent The consumed inhalational agent ml will be converted to tones by volume weight conversion formula 1465 for Desflurane and 1522 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None