Evaluation of the Sevoflurane Consumption During General Anesthesia When Using the MemsorbTM Membrane and Low Gas Flow Versus the Classical Chemical Absorbents With 2L.Min-1 Gas Flow for CO2 Removal From the Anesthesia Circuit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To show a significant decrease of at least 25% of the sevoflurane consumption
研究概览
简要总结
The study aims at determining whether replacing the classical chemical absorber Dräegersorb 800+ on Dräeger Perseus A500 machines (Dräeger, Lübeck, Germany) by the new membrane technology-based product (Memsorb™, DMF Medical Inc., Halifax, NS, Canada) with the help of high-quality monitoring (BIS and NOL) and high-end ventilators (Dräeger Perseus A500 machines; Dräeger, Lübeck, Germany) that allow minimal fresh gas flow, will significantly decrease the use of sevoflurane and its related atmospheric pollution.
详细描述
Assessing the impact of anesthesia practice on global warming and carbon footprint becomes part of the standard of care and is a 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. The time period used, 20 versus 100 years, might drastically change the way we see impact of anesthesia on climate changes and GWP20 of CO2 is, by definition set at "1". Inhaled anesthetics have various GWP20: 349 for sevoflurane and 3714 for desflurane. These numbers might slightly change from one to another report/study. 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-1 that must be used for sevoflurane according to its monography when classical chemical absorbents are used by the anesthesia team. 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.
For sevoflurane, the standard FGF must be set at 2L.min-1 as there is still controversy concerning impact on renal function at lower flows if classical CO2 absorbents are used. It is still not recommended to administer sevoflurane during anesthesia with a FGF lower than 2L.min-1 in Canada when classical chemical absorbents are used according to Baxter monography when classical absorbents are used on the anesthesia circuit (http://www.baxter.ca/fr_CA/assets/downloads/monographs/Sevoflurane_FR.pdf). When continuous and accurate gas monitoring and analysis is used as recommended nowadays by all GCP guidelines (see Canadian guidelines for anesthesia practice), 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.
Moreover, there are few clinical trials looking at the sparing effect on the consumption of anesthetic gases when the depth of anesthesia is properly monitored, with the bispectral index for instance. Indeed, and because the lack of appropriate and precise technology at the time of completion of these trials, most of the studies used only end-tidal concentration in % of the anesthetic gases to argue that they had decreased the consumption of gas during surgery. This remains a very indirect assessing method based on extrapolations as opposed to direct measurements. Studying the effect of the combination of BIS/NOL indices (depth of hypnosis / depth of analgesia) monitoring and the use of our Drager ventilators with low-FGF on precise consumption in mL of each gas in a clinical environment allows to get high quality data never reported in the past. The fact this study also uses the NOL index to ensure that level of analgesia is controlled and equivalent in all groups will also reinforce the idea that what this study measures in terms of anesthetic gas consumption is based on the real need for hypnosis for each participant, and not an overconsumption of gas because of poor control of nociception and analgesia.
Recently a new device was developed to extract CO2 from the ventilation-anesthesia circuit: the new membrane technology-based product (Memsorb™, DMF Medical Inc., Halifax, NS, Canada). All details on the technology of this new membrane are given in the Appendix 1 attached to this proposal (see at the bottom of the present text).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique,
- •Fully consented,
- •BMI < 40,
- •Age > 18.
排除标准
- •Allergy or contra-indication to any drug used in the study protocol,
- •History of unstable coronary artery disease,
- •Serious cardiac arrhythmia (including atrial fibrillation),
- •History of substance abuse in the last 2 months prior to surgery,
- •Chronic use of psychotropic and/or opioid drugs (still existing within the last month prior to surgery,
- •History of psychiatric diseases,
- •History of refractory PONV in previous surgery,
- •Allergy to any drug used in the study protocol,
- •Non-scheduled surgery,
- •Refusal of the patient for participation in the study.
结局指标
主要结局
To show a significant decrease of at least 25% of the sevoflurane consumption
时间窗: Intraoperative
To compare the total sevoflurane consumption when using MemsorbTM versus DrägersorbTM. This will be expressed in mL.kg-1.h-1 of surgery and the primary objective will focus on H1 of surgery, H1 starting at the time of incision (T0).
次要结局
- To evaluate the pollution induced by anesthesia at H1 of surgery and consequent hours(Intraoperative)
- To evaluate the levels of expired CO2(Intraoperative)
- To evaluate sevoflurane consumption for each hour of surgery(Intraoperative)
- To evaluate the global costs of sevoflurane consumption(Intraoperative)
研究者
Philippe Richebe
MD, PhD, Professor with Tenure, Director of Research, Department of Anesthesiology and Pain Medicine, University of Montreal (UDeM), Maisonneuve Rosemont Hospital, CEMTL
Ciusss de L'Est de l'Île de Montréal
