Pub Date : 2024-05-06DOI: 10.1016/j.accpm.2024.101389
Matthieu Jabaudon , Bhadrish Vallabh , H. Peter Bacher , Rafael Badenes , Franz Kehl
Discussions of the environmental impacts of general anesthetics have focused on greenhouse gas (GHG) emissions from inhaled agents, with those of total intravenous anesthesia (TIVA) recently coming to the forefront. Clinical experts are calling for the expansion of research toward life cycle assessment (LCA) to comprehensively study the impact of general anesthetics. We provide an overview of proposed environmental risks, including direct GHG emissions from inhaled anesthetics and non-GHG impacts and indirect GHG emissions from propofol. A practical description of LCA methodology is also provided, as well as how it applies to the study of general anesthesia. We describe available LCA studies comparing the environmental impacts of a lower carbon footprint inhaled anesthetic, sevoflurane, to TIVA/propofol and discuss their life cycle steps: manufacturing, transport, clinical use, and disposal. Significant hotspots of GHG emission were identified as the manufacturing and disposal of sevoflurane and use (attributed to the manufacture of the required syringes and syringe pumps) for propofol. However, the focus of these studies was solely on GHG emissions, excluding other environmental impacts of wasted propofol, such as water/soil toxicity. Other LCA gaps included a lack of comprehensive GHG emission estimates related to the manufacturing of TIVA plastic components, high-temperature incineration of propofol, and gas capture technologies for inhaled anesthetics. Considering that scarce LCA evidence does not allow for a definite conclusion to be drawn regarding the overall environmental impacts of sevoflurane and TIVA, we conclude that current anesthetic practice involving these agents should focus on patient needs and established best practices as more LCA research is accumulated.
{"title":"Balancing patient needs with environmental impacts for best practices in general anesthesia: Narrative review and clinical perspective","authors":"Matthieu Jabaudon , Bhadrish Vallabh , H. Peter Bacher , Rafael Badenes , Franz Kehl","doi":"10.1016/j.accpm.2024.101389","DOIUrl":"10.1016/j.accpm.2024.101389","url":null,"abstract":"<div><p>Discussions of the environmental impacts of general anesthetics have focused on greenhouse gas (GHG) emissions from inhaled agents, with those of total intravenous anesthesia (TIVA) recently coming to the forefront. Clinical experts are calling for the expansion of research toward life cycle assessment (LCA) to comprehensively study the impact of general anesthetics. We provide an overview of proposed environmental risks, including direct GHG emissions from inhaled anesthetics and non-GHG impacts and indirect GHG emissions from propofol. A practical description of LCA methodology is also provided, as well as how it applies to the study of general anesthesia. We describe available LCA studies comparing the environmental impacts of a lower carbon footprint inhaled anesthetic, sevoflurane, to TIVA/propofol and discuss their life cycle steps: manufacturing, transport, clinical use, and disposal. Significant hotspots of GHG emission were identified as the manufacturing and disposal of sevoflurane and use (attributed to the manufacture of the required syringes and syringe pumps) for propofol. However, the focus of these studies was solely on GHG emissions, excluding other environmental impacts of wasted propofol, such as water/soil toxicity. Other LCA gaps included a lack of comprehensive GHG emission estimates related to the manufacturing of TIVA plastic components, high-temperature incineration of propofol, and gas capture technologies for inhaled anesthetics. Considering that scarce LCA evidence does not allow for a definite conclusion to be drawn regarding the overall environmental impacts of sevoflurane and TIVA, we conclude that current anesthetic practice involving these agents should focus on patient needs and established best practices as more LCA research is accumulated.</p></div>","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 4","pages":"Article 101389"},"PeriodicalIF":3.7,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140867167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-04DOI: 10.1016/j.accpm.2024.101385
Proshad N. Efune , Pedro Pinales , Jenny Park , Kiley F. Poppino , Ron B. Mitchell , Peter Szmuk
Background
Adenotonsillectomy is often curative for pediatric obstructive sleep apnea, yet children remain at high risk of respiratory complications in the postoperative period. We sought to determine the incidence and risk factors for respiratory depression and airway obstruction, as well as clinically apparent respiratory events in the post-anesthesia care unit (PACU) in high-risk children after adenotonsillectomy.
Methods
In this prospective cohort study, we enrolled 60 high-risk children having adenotonsillectomy. Our primary outcome was respiratory depression and airway obstruction in the PACU measured using a noninvasive respiratory volume monitor (RVM) and defined by episodes of predicted minute ventilation less than 40% for at least 2 min. We measured clinically apparent respiratory events using continuous observation by trained study staff.
Results
The median (range) age of our sample was 4 years (1, 16) and 27 (45%) were female. Black and Hispanic race children comprised 80% (n = 48) of our cohort. Thirty-nine (65%) had at least one episode of PACU respiratory depression or airway obstruction measured using the RVM, while only 21 (35%) had clinically apparent respiratory events. Poisson regression demonstrated the following associations with an increase in episodes of respiratory depression and airway obstruction: BMI Z-score less than −1 (estimate 3.91; [95%CI 1.49–10.23]), BMI Z-score 1–2 (estimate 2.04; [1.20–3.48]), and two or more comorbidities (estimate 1.96; [1.11–3.46]).
Conclusions
Respiratory volume monitoring in the immediate postoperative period after pediatric high-risk adenotonsillectomy identifies impaired ventilation more frequently than is clinically apparent.
{"title":"Pediatric obstructive sleep apnea: a prospective observational study of respiratory events in the immediate recovery period after adenotonsillectomy","authors":"Proshad N. Efune , Pedro Pinales , Jenny Park , Kiley F. Poppino , Ron B. Mitchell , Peter Szmuk","doi":"10.1016/j.accpm.2024.101385","DOIUrl":"10.1016/j.accpm.2024.101385","url":null,"abstract":"<div><h3>Background</h3><p>Adenotonsillectomy is often curative for pediatric obstructive sleep apnea, yet children remain at high risk of respiratory complications in the postoperative period. We sought to determine the incidence and risk factors for respiratory depression and airway obstruction, as well as clinically apparent respiratory events in the post-anesthesia care unit (PACU) in high-risk children after adenotonsillectomy.</p></div><div><h3>Methods</h3><p>In this prospective cohort study, we enrolled 60 high-risk children having adenotonsillectomy. Our primary outcome was respiratory depression and airway obstruction in the PACU measured using a noninvasive respiratory volume monitor (RVM) and defined by episodes of predicted minute ventilation less than 40% for at least 2 min. We measured clinically apparent respiratory events using continuous observation by trained study staff.</p></div><div><h3>Results</h3><p>The median (range) age of our sample was 4 years (1, 16) and 27 (45%) were female. Black and Hispanic race children comprised 80% (n = 48) of our cohort. Thirty-nine (65%) had at least one episode of PACU respiratory depression or airway obstruction measured using the RVM, while only 21 (35%) had clinically apparent respiratory events. Poisson regression demonstrated the following associations with an increase in episodes of respiratory depression and airway obstruction: BMI Z-score less than −1 (estimate 3.91; [95%CI 1.49–10.23]), BMI Z-score 1–2 (estimate 2.04; [1.20–3.48]), and two or more comorbidities (estimate 1.96; [1.11–3.46]).</p></div><div><h3>Conclusions</h3><p>Respiratory volume monitoring in the immediate postoperative period after pediatric high-risk adenotonsillectomy identifies impaired ventilation more frequently than is clinically apparent.</p></div>","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 4","pages":"Article 101385"},"PeriodicalIF":3.7,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140873051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-04DOI: 10.1016/j.accpm.2024.101383
Adrian Wong , Jihad Mallat , Marc-Olivier Fischer
{"title":"New approach of classifying venous congestion in critically ill patients based on unsupervised machine-learning technique","authors":"Adrian Wong , Jihad Mallat , Marc-Olivier Fischer","doi":"10.1016/j.accpm.2024.101383","DOIUrl":"10.1016/j.accpm.2024.101383","url":null,"abstract":"","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 3","pages":"Article 101383"},"PeriodicalIF":5.5,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140865523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-04DOI: 10.1016/j.accpm.2024.101388
Yann Le Teurnier , Bertrand Rozec , Cecile Degryse , François Levy , Youcef Miliani , Gilles Godet , Georges Daccache , Cyrille Truc , Eric Steinmetz , Alexandre Ouattara , Bernard Cholley , Jean-Marc Malinovsky , Denis Portier , Gregory Dupont , Darius Liutkus , Pierre Viard , Morgane Pere , Benjamin Daumas-Duport , Pierre-Aubin Magras , Mickael Vourc’h
Background
Whether the optimization of cerebral oxygenation based on regional cerebral oxygen saturation (rSO2) monitoring reduces the occurrence of cerebral ischemic lesions is unknown.
Methods
This multicenter, randomized, controlled trial recruited adults admitted for scheduled carotid endarterectomy. Patients were randomized between the standard of care or optimization of cerebral oxygenation based on rSO2 monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO2 in the intervention, the following treatments were sequentially recommended: (1) increasing oxygenotherapy, (2) reducing the tidal volume, (3) legs up-raising, (4) performing a fluid challenge and (5) initiating vasopressor support. The primary endpoint was the number of new cerebral ischemic lesions detected using magnetic resonance imaging pre- and postoperatively. Secondary endpoints included new neurological deficits and mortality on day 120 after surgery.
Results
Among the 879 patients who were randomized, 665 (75.7%) were men. There was no statistically significant difference between groups for the mean number of new cerebral ischemic lesions per patient up to 3 days after surgery: 0.35 (±1.05) in the standard group vs. 0.58 (±2.83), in the NIRS group; mean difference, 0.23 [95% CI, −0.06 to 0.52]; estimate, 0.22 [95% CI, −0.06 to 0.50]. New neurological deficits up to day 120 after hospital discharge were not different between the groups: 15 (3,39%) in the standard group vs. 42 (5,49%) in the NIRS group; absolute difference, 2,10 [95% CI, −0,62 to 4,82]. There was no significant difference between groups for the median [IQR] hospital length of stay: 4.0 [4.0–6.0] in the standard group vs. 5.0 [4.0–6.0] in the NIRS group; mean difference, −0.11 [95% CI, −0.65 to 0.44]. The mortality rate on day 120 was not different between the standard group (0.68%) vs. the NIRS group (0.92%); absolute difference = 0.24% [95% CI, −0.94 to 1.41].
Conclusions
Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.
{"title":"Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial","authors":"Yann Le Teurnier , Bertrand Rozec , Cecile Degryse , François Levy , Youcef Miliani , Gilles Godet , Georges Daccache , Cyrille Truc , Eric Steinmetz , Alexandre Ouattara , Bernard Cholley , Jean-Marc Malinovsky , Denis Portier , Gregory Dupont , Darius Liutkus , Pierre Viard , Morgane Pere , Benjamin Daumas-Duport , Pierre-Aubin Magras , Mickael Vourc’h","doi":"10.1016/j.accpm.2024.101388","DOIUrl":"10.1016/j.accpm.2024.101388","url":null,"abstract":"<div><h3>Background</h3><p>Whether the optimization of cerebral oxygenation based on regional cerebral oxygen saturation (rSO<sub>2</sub>) monitoring reduces the occurrence of cerebral ischemic lesions is unknown.</p></div><div><h3>Methods</h3><p>This multicenter, randomized, controlled trial recruited adults admitted for scheduled carotid endarterectomy. Patients were randomized between the standard of care or optimization of cerebral oxygenation based on rSO<sub>2</sub> monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO<sub>2</sub> in the intervention, the following treatments were sequentially recommended: (1) increasing oxygenotherapy, (2) reducing the tidal volume, (3) legs up-raising, (4) performing a fluid challenge and (5) initiating vasopressor support. The primary endpoint was the number of new cerebral ischemic lesions detected using magnetic resonance imaging pre- and postoperatively. Secondary endpoints included new neurological deficits and mortality on day 120 after surgery.</p></div><div><h3>Results</h3><p>Among the 879 patients who were randomized, 665 (75.7%) were men. There was no statistically significant difference between groups for the mean number of new cerebral ischemic lesions per patient up to 3 days after surgery: 0.35 (<strong>±</strong>1.05) in the standard group <em>vs.</em> 0.58 (<strong>±</strong>2.83), in the NIRS group; mean difference, 0.23 [95% CI, −0.06 to 0.52]; estimate, 0.22 [95% CI, −0.06 to 0.50]. New neurological deficits up to day 120 after hospital discharge were not different between the groups: 15 (3,39%) in the standard group <em>vs.</em> 42 (5,49%) in the NIRS group; absolute difference, 2,10 [95% CI, −0,62 to 4,82]. There was no significant difference between groups for the median [IQR] hospital length of stay: 4.0 [4.0–6.0] in the standard group <em>vs.</em> 5.0 [4.0–6.0] in the NIRS group; mean difference, −0.11 [95% CI, −0.65 to 0.44]. The mortality rate on day 120 was not different between the standard group (0.68%) <em>vs.</em> the NIRS group (0.92%); absolute difference = 0.24% [95% CI, −0.94 to 1.41].</p></div><div><h3>Conclusions</h3><p>Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO<sub>2</sub> did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.</p></div><div><h3>Trial registration</h3><p>ClinicalTrials.gov identifier: NCT01415648.</p></div>","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 4","pages":"Article 101388"},"PeriodicalIF":3.7,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352556824000468/pdfft?md5=cd274378313fad99e946a95c75ec61d0&pid=1-s2.0-S2352556824000468-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140863840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.1016/j.accpm.2024.101379
Katherine B. Hagan , Emmanuel Coronel , Phillip Ge , Carin Hagberg
{"title":"A randomized controlled trial of the LMA® Gastro™ compared to nasal cannula for endoscopic retrograde cholangiopancreatography","authors":"Katherine B. Hagan , Emmanuel Coronel , Phillip Ge , Carin Hagberg","doi":"10.1016/j.accpm.2024.101379","DOIUrl":"10.1016/j.accpm.2024.101379","url":null,"abstract":"","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 4","pages":"Article 101379"},"PeriodicalIF":3.7,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140177323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.1016/j.accpm.2024.101378
Antoine Charles , Sandrine Jaffre , Karim Lakhal , Raphael Cinotti , Corinne Lejus-Bourdeau
{"title":"Evaluation of preoxygenation devices using a lung simulator mimicking normal adult spontaneous breathing","authors":"Antoine Charles , Sandrine Jaffre , Karim Lakhal , Raphael Cinotti , Corinne Lejus-Bourdeau","doi":"10.1016/j.accpm.2024.101378","DOIUrl":"10.1016/j.accpm.2024.101378","url":null,"abstract":"","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 4","pages":"Article 101378"},"PeriodicalIF":3.7,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140177324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To date, there is no instrument to adequately assess self-reported quality of recovery (QoR) in the post-anesthesia care unit (PACU). We previously developed the QoR-PACU, a 13-item questionnaire specifically applicable to the PACU. The feasibility, acceptance, and validity of the QoR-PACU were promising. However, measures of reliability were slightly lower than expected.
Methods
We modified the QoR-PACU and evaluated its psychometric properties in a cohort of adult patients scheduled for non-cardiac surgery with general anesthesia. The modified QoR-PACU (termed QoR-PACU2) was administered before surgery and postoperatively in the PACU at the time of the decision to discharge.
Results
A total of 307 patients were included in the final analysis. Postoperative QoR-PACU2 sum scores differed across categories of sex, perioperative and surgical risk, and modes of airway management. The duration of anesthesia and surgery, maximum pain intensity and analgesic requirement in the PACU, and length of PACU stay were all inversely correlated with QoR in the PACU. Cronbach’s alpha was 0.70 (95%CI: 0.66–0.75). The intra-class correlation coefficient was 0.86 (95%CI: 0.70–0.94, p < 0.001) for intra-rater reliability (n = 24) and 0.94 (95%CI 0.90 to 0.97, p < 0.001) for inter-rater reliability (n = 31). Cohen’s effect size was 0.68 and the standardized response mean was 0.57.
Conclusion
The QoR-PACU2 assesses self-reported QoR after surgery in the PACU. Measures of feasibility, validity, and reliability were consistently high. Measures of responsiveness were moderate, which might be attributable to the heterogeneity of the study population. Future studies should include aspects of ethnicity and cross-cultural applicability.
{"title":"Psychometric evaluation of the modified quality of recovery score for the postanaesthesia care unit (QoR-PACU2)—A prospective validation study","authors":"Ursula Kahl , Alena Boehm , Linda Krause , Regine Klinger , Kaloyan Stoimenov , Christian Zöllner , Lili Plümer , Marlene Fischer","doi":"10.1016/j.accpm.2024.101380","DOIUrl":"10.1016/j.accpm.2024.101380","url":null,"abstract":"<div><h3>Background</h3><p>To date, there is no instrument to adequately assess self-reported quality of recovery (QoR) in the post-anesthesia care unit (PACU). We previously developed the QoR-PACU, a 13-item questionnaire specifically applicable to the PACU. The feasibility, acceptance, and validity of the QoR-PACU were promising. However, measures of reliability were slightly lower than expected.</p></div><div><h3>Methods</h3><p>We modified the QoR-PACU and evaluated its psychometric properties in a cohort of adult patients scheduled for non-cardiac surgery with general anesthesia. The modified QoR-PACU (termed QoR-PACU<sub>2</sub>) was administered before surgery and postoperatively in the PACU at the time of the decision to discharge.</p></div><div><h3>Results</h3><p>A total of 307 patients were included in the final analysis. Postoperative QoR-PACU<sub>2</sub> sum scores differed across categories of sex, perioperative and surgical risk, and modes of airway management. The duration of anesthesia and surgery, maximum pain intensity and analgesic requirement in the PACU, and length of PACU stay were all inversely correlated with QoR in the PACU. Cronbach’s alpha was 0.70 (95%CI: 0.66–0.75). The intra-class correlation coefficient was 0.86 (95%CI: 0.70–0.94, <em>p</em> < 0.001) for intra-rater reliability (<em>n</em> = 24) and 0.94 (95%CI 0.90 to 0.97, <em>p</em> < 0.001) for inter-rater reliability (<em>n</em> = 31). Cohen’s effect size was 0.68 and the standardized response mean was 0.57.</p></div><div><h3>Conclusion</h3><p>The QoR-PACU<sub>2</sub> assesses self-reported QoR after surgery in the PACU. Measures of feasibility, validity, and reliability were consistently high. Measures of responsiveness were moderate, which might be attributable to the heterogeneity of the study population. Future studies should include aspects of ethnicity and cross-cultural applicability.</p></div>","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 3","pages":"Article 101380"},"PeriodicalIF":5.5,"publicationDate":"2024-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352556824000389/pdfft?md5=49b33d0fe230a44f4650f4416c365246&pid=1-s2.0-S2352556824000389-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140159339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-15DOI: 10.1016/j.accpm.2024.101376
Emmanuel Novy , Xin Liu , María Patricia Hernández-Mitre , Thibaut Belveyre , Julien Scala-Bertola , Jason A. Roberts , Suzanne L. Parker
Background
This study describes the population pharmacokinetics of cefoxitin in obese patients undergoing elective bariatric surgery and evaluates different dosing regimens for achievement of pre-defined target exposures.
Methods
Serial blood samples were collected during surgery with relevant clinical data. Total serum cefoxitin concentrations were measured by chromatographic assay and analysed using a population PK approach with Pmetrics®. The cefoxitin unbound fraction (fu) was estimated. Dosing simulations were performed to ascertain the probability of target attainment (PTA) to achieve cefoxitin fu above minimum inhibitory concentrations (MIC) from surgical incision to wound closure. Fractional target attainment (FTA) was calculated against MIC distributions of common pathogens.
Results
A total of 123 obese patients (median BMI 44.3 kg/m2) were included with 381 cefoxitin concentration values. Cefoxitin was best described by a one-compartment model, with a mean clearance and volume of distribution of 10.9 ± 6.1 L/h and 23.4 ± 10.5 L, respectively. In surgery <2 h, a 2 and a 4 g doses were sufficient for an MIC up to 4 and 8 mg/L (fu 50%), respectively. In prolonged surgery (2–4 h), only continuous infusion enabled optimal PTA for an MIC up to 16 mg/L. Optimal FTAs were obtained against Staphylococcus aureus and Escherichia Coli only when simulating with 50% cefoxitin protein binding (intermittent regimen) and regardless of the protein binding for the continuous infusion.
Conclusion
Intermittent dosing regimens resulted in optimal FTAs against susceptible MIC distributions of S. aureus and E. coli when simulating with 50% cefoxitin protein binding. Continuous infusion of cefoxitin may improve FTA regardless of protein binding.
{"title":"Population pharmacokinetics of prophylactic cefoxitin in elective bariatric surgery patients: a prospective monocentric study","authors":"Emmanuel Novy , Xin Liu , María Patricia Hernández-Mitre , Thibaut Belveyre , Julien Scala-Bertola , Jason A. Roberts , Suzanne L. Parker","doi":"10.1016/j.accpm.2024.101376","DOIUrl":"10.1016/j.accpm.2024.101376","url":null,"abstract":"<div><h3>Background</h3><p>This study describes the population pharmacokinetics of cefoxitin in obese patients undergoing elective bariatric surgery and evaluates different dosing regimens for achievement of pre-defined target exposures.</p></div><div><h3>Methods</h3><p>Serial blood samples were collected during surgery with relevant clinical data. Total serum cefoxitin concentrations were measured by chromatographic assay and analysed using a population PK approach with Pmetrics®. The cefoxitin unbound fraction (fu) was estimated. Dosing simulations were performed to ascertain the probability of target attainment (PTA) to achieve cefoxitin fu above minimum inhibitory concentrations (MIC) from surgical incision to wound closure. Fractional target attainment (FTA) was calculated against MIC distributions of common pathogens.</p></div><div><h3>Results</h3><p>A total of 123 obese patients (median BMI 44.3 kg/m<sup>2</sup>) were included with 381 cefoxitin concentration values. Cefoxitin was best described by a one-compartment model, with a mean clearance and volume of distribution of 10.9 ± 6.1 L/h and 23.4 ± 10.5 L, respectively. In surgery <2 h, a 2 and a 4 g doses were sufficient for an MIC up to 4 and 8 mg/L (fu 50%), respectively. In prolonged surgery (2–4 h), only continuous infusion enabled optimal PTA for an MIC up to 16 mg/L. Optimal FTAs were obtained against <em>Staphylococcus aureus</em> and <em>Escherichia Coli</em> only when simulating with 50% cefoxitin protein binding (intermittent regimen) and regardless of the protein binding for the continuous infusion.</p></div><div><h3>Conclusion</h3><p>Intermittent dosing regimens resulted in optimal FTAs against susceptible MIC distributions of <em>S. aureus</em> and <em>E. coli</em> when simulating with 50% cefoxitin protein binding. Continuous infusion of cefoxitin may improve FTA regardless of protein binding.</p></div><div><h3>Study registration</h3><p>Registration on ClinicalTrials.gov, NCT03306290</p></div>","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 3","pages":"Article 101376"},"PeriodicalIF":5.5,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-15DOI: 10.1016/j.accpm.2024.101377
Chen Yang , Jing Jiao , Yuyan Nie , Wenyu Shao , Hongwei Zhang , Shaoqiang Huang
Background
Remimazolam is a safe and effective new benzodiazepine sedative that has unique advantages in anesthesia induction and maintenance. The differences in the electroencephalogram bispectral index (BIS) during general anesthesia between propofol and remimazolam deserve further exploration.
Methods
Single-center randomized crossover study. Patients who required multiple hysteroscopic surgery were randomly assigned to use remimazolam (0.27 mg/kg for induction and 1 mg/kg/h for maintenance) first and then propofol (2.0 mg/kg for induction and 6 mg/kg/h for maintenance) during hysteroscopic surgery again 3 months later, or in the opposite order. Both drugs were used at the latest ED95 for unconsciousness. The BIS values (primary endpoint), intraoperative conditions, and incidence of adverse reactions (secondary endpoints) were compared at each time point. BIS values were analyzed with a mixed model of repeated measurements (MMRM).
Results
Seventeen patients completed the study. The lowest BIS value in the remimazolam regimen was significantly higher than that in the propofol regimen (p = 0.001). The MMRM analysis of the BIS values revealed significant differences between the regimens at each time point (p < 0.001). The intraoperative diastolic blood pressure and heart rate changes were smaller, the recovery was faster, and there were fewer adverse reactions and less injection pain, but a greater incidence of intraoperative body movement and hiccups, in the remimazolam regimen.
Conclusion
The trial indicated that remimazolam maintained a higher BIS level than propofol. The correlation between the BIS and the depth of anesthesia induced by remimazolam needs to be further studied.
Trial registration
This trial is registered at ClinicalTrials.gov: ChiCTR2200064551
背景:雷马唑仑是一种安全有效的新型苯二氮卓镇静剂,在麻醉诱导和维持中具有独特的优势。丙泊酚和雷马唑仑在全身麻醉期间脑电图双谱指数(BIS)的差异值得进一步探讨:方法:单中心随机交叉研究。需要多次接受宫腔镜手术的患者被随机分配到先使用瑞马唑仑(0.27 mg/kg 用于诱导,1 mg/kg/h 用于维持),然后在 3 个月后再次接受宫腔镜手术时使用异丙酚(2.0 mg/kg 用于诱导,6 mg/kg/h 用于维持),或者使用相反的顺序。两种药物的使用剂量均为昏迷的最新 ED95。比较了每个时间点的 BIS 值(主要终点)、术中情况和不良反应发生率(次要终点)。BIS 值采用重复测量混合模型(MMRM)进行分析:17名患者完成了研究。瑞马唑仑方案的最低 BIS 值明显高于异丙酚方案(p = 0.001)。对 BIS 值进行的 MMRM 分析表明,各时间点的方案之间存在显著差异(p 结论:BIS 值与异丙酚方案之间存在显著差异(p = 0.001):试验表明,与异丙酚相比,雷马唑仑能维持更高的 BIS 水平。BIS与雷马唑仑诱导的麻醉深度之间的相关性有待进一步研究:本试验已在 ClinicalTrials.gov 注册:ChiCTR2200064551。
{"title":"Comparison of the bispectral indices of patients receiving remimazolam and propofol for general anesthesia: a randomized crossover trial","authors":"Chen Yang , Jing Jiao , Yuyan Nie , Wenyu Shao , Hongwei Zhang , Shaoqiang Huang","doi":"10.1016/j.accpm.2024.101377","DOIUrl":"10.1016/j.accpm.2024.101377","url":null,"abstract":"<div><h3>Background</h3><p>Remimazolam is a safe and effective new benzodiazepine sedative that has unique advantages in anesthesia induction and maintenance. The differences in the electroencephalogram bispectral index (BIS) during general anesthesia between propofol and remimazolam deserve further exploration.</p></div><div><h3>Methods</h3><p>Single-center randomized crossover study. Patients who required multiple hysteroscopic surgery were randomly assigned to use remimazolam (0.27 mg/kg for induction and 1 mg/kg/h for maintenance) first and then propofol (2.0 mg/kg for induction and 6 mg/kg/h for maintenance) during hysteroscopic surgery again 3 months later, or in the opposite order. Both drugs were used at the latest ED<sub>95</sub> for unconsciousness. The BIS values (primary endpoint), intraoperative conditions, and incidence of adverse reactions (secondary endpoints) were compared at each time point. BIS values were analyzed with a mixed model of repeated measurements (MMRM).</p></div><div><h3>Results</h3><p>Seventeen patients completed the study. The lowest BIS value in the remimazolam regimen was significantly higher than that in the propofol regimen (<em>p</em> = 0.001). The MMRM analysis of the BIS values revealed significant differences between the regimens at each time point (<em>p</em> < 0.001). The intraoperative diastolic blood pressure and heart rate changes were smaller, the recovery was faster, and there were fewer adverse reactions and less injection pain, but a greater incidence of intraoperative body movement and hiccups, in the remimazolam regimen.</p></div><div><h3>Conclusion</h3><p>The trial indicated that remimazolam maintained a higher BIS level than propofol. The correlation between the BIS and the depth of anesthesia induced by remimazolam needs to be further studied.</p></div><div><h3>Trial registration</h3><p>This trial is registered at ClinicalTrials.gov: ChiCTR2200064551</p></div>","PeriodicalId":48762,"journal":{"name":"Anaesthesia Critical Care & Pain Medicine","volume":"43 3","pages":"Article 101377"},"PeriodicalIF":5.5,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}