NCT04163848

Brief Summary

Assessing the impact of anesthesia practice on global warming and carbon footprint becomes part of the standard of care and is growing concern within the anesthesia community. Global Warming Potential (GWP) is a measure of how much a given mass of greenhouse gas contributes to global warming over a specified time period. Inhaled anesthetics have various GWP20: 349 for sevoflurane and 3714 for desflurane. However, GWP20 and CDE20 alone are not sufficient to evaluate the environmental impact of anesthetic gases. Other parameters must be included in the analysis: fresh gas flow (FGF), carrier gas (air, O2, N2O) and potency of the anesthetic gas. Unfortunately, the majority of trials did not fully consider the FGF reduction and the fact that desflurane can be administered with new closed or very low-flow anesthesia circuits as opposed as the recommended 2L/min that must be used for sevoflurane according to its monography in Canada. Most of the calculations were made on a purely theoretical approach that could be different from actual measurements based on a strictly monitored anesthesia practice. When continuous and accurate gas monitoring and analysis is used as recommended nowadays, the use of closed or semi-closed-circuit anesthesia with very low FGF might allow for a reduction of more than 80% of the anesthetic gas administration and its consequent pollution. By properly monitoring the anesthesia depth and analgesia adequacy, the investigators can reduce the gas consumption. The proposed study will aim at determining whether with the help of high-quality monitoring (BIS and NOL) and high-end ventilators that allow minimal fresh gas flow, the use of desflurane remains more polluting than sevoflurane.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

November 6, 2019

Last Update Submit

January 26, 2021

Conditions

Keywords

DesfluraneSevofluraneFresh gas flowEnvironment

Outcome Measures

Primary Outcomes (1)

  • CO2 equivalent of volatile inhaled anesthesic gases use in grams

    To compare total volatile inhaled anesthetics consumption in CO2 equivalent (grams) per hour during anesthesia for laparoscopic surgery between two groups: Group "D" for Desflurane and group "S" for Sevoflurane

    From intubation to end of surgery

Secondary Outcomes (4)

  • Total volatile inhalated anesthesics consumption in mL

    From intubation to end of surgery

  • Cost in dollars

    From intubation to end of surgery

  • Extubation time in minutes

    From stopping anesthesics gases to extubation

  • Recovery room time in minutes

    From end of surgery to 240minutes post-surgery

Study Arms (2)

Desflurane

desflurane administration based on a BIS index kept between 40-60 and with use of the semi-closed circuit of the Draeger A500 ventilator and its econometer for an optimized fresh gas flow as low as the O2 consumption allows

Other: Pollution

Sevoflurane

sevoflurane administration based on a BIS kept between 40-60 and with use of the semi-closed circuit of the Draeger A500 ventilator with a fixed fresh gas flow of 2L/min as requested in the gas monography

Other: Pollution

Interventions

CO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery

DesfluraneSevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General population undergoing laparoscopic gynecologic, urologic or general surgery

You may qualify if:

  • ASA 1-3 patients,
  • laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique
  • fully consented,
  • BMI \< 40,
  • age \> 18yo,

You may not qualify if:

  • post-operative need for a neuraxial or regional analgesic technique
  • history of active coronary artery disease
  • serious cardiac arrhythmia (including atrial fibrillation)
  • history of substance abuse
  • chronic use of psychotropic and/or opioid drugs
  • history of psychiatric diseases with the need of medication
  • history of refractory PONV
  • allergy or contra-indication to any drug used in the study protocol
  • refusal of the patient for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Mucopolysaccharidosis IVRespiratory Aspiration

Condition Hierarchy (Ancestors)

MucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Deputy chief of the Department of Anesthesiology of Maisonneuve-Rosemont Hospital, University of Montreal(UDeM)

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 15, 2019

Study Start

September 25, 2019

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations