Project description:ObjectiveDecreased postoperative sleep quality remains a serious problem in surgical settings at present. The purpose of our study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.MethodsSeventy-four patients undergoing selective laparoscopic surgery under general anesthesia were randomly assigned to the propofol group or sevoflurane group. The wireless portable sleep monitor (WPSM) is used to collect sleep quality on the night before surgery (sleep preop 1), the first night after surgery (sleep POD 1), and the third night after surgery (sleep POD 3). Record the subjective sleep quality and dreaming state during the operation. The perioperative hemodynamics, postoperative sleep and complications were also evaluated.ResultsCompared with Sleep preop 1, patients showed lower sleep efficiency, Stable sleep and Unstable sleep during Sleep POD 1 and Sleep POD 3. In addition, compared with the propofol group, the proportion of REM sleep in the sevoflurane group was much higher during Sleep POD 1 and Sleep POD 3, and the incidence of dreaming was also higher in the sevoflurane group. Patients in the propofol group had better pain relief at 2, 4, and 6 hours after surgery. And the incidence of postoperative nausea and vomiting and dizziness in the sevoflurane group was significantly higher than that in the propofol group.ConclusionThe degree of postoperative sleep efficiency was better on Sleep POD1 and Sleep POD3; the incidence of postoperative nausea and vomiting, and dizziness was lower; and postoperative pain was slighter when the operation was performed under propofol anesthesia compared with patients in the sevoflurane group. Propofol should be considered a better choice during the operation to promote the patient's postoperative sleep quality, relieve postoperative pain and improve the incidence of postoperative dizziness and nausea and vomiting.
Project description:IntroductionThe use of sedation in intensive care units (ICUs) is necessary and ubiquitous. The impact of sedation strategy on outcome, particularly when delivered early after initiation of mechanical ventilation, is unknown. Evidence is increasing that volatile anaesthetic agents could be associated with better outcome. Their use in delirium prevention is unknown.Methods and analysisThis study is an investigator-initiated, prospective, multicentre, two-arm, randomised, control, open-trial comparing inhaled sedation strategy versus intravenous sedation strategy in mechanically ventilated patients in ICU. Two hundred and fifty patients will be randomly assigned to the intravenous sedation group or inhaled sedation group, with a 1:1 ratio in two groups according to the sedation strategy. The primary outcome is the occurrence of delirium assessed using two times a day confusion assessment method for the ICU (CAM-ICU). Secondary outcomes include cognitive and functional outcomes at 3 and 12 months.Ethics and disseminationThe study has been approved by the Regional Ethics Committee (CPP Ouest) and national authorities (ANSM). The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04341350.
Project description:Background and objectivesThe coronavirus disease 2019 (COVID-19) pandemic and the shortage of intravenous sedatives has led to renewed interest in inhaled sedation for patients with acute respiratory distress syndrome (ARDS). We hypothesized that inhaled sedation would be associated with improved clinical outcomes in COVID-19 ARDS patients.MethodsRetrospective international study including mechanically ventilated patients with COVID-19 ARDS who required sedation and were admitted to 10 European and US intensive care units. The primary endpoint of ventilator-free days through day 28 was analyzed using zero-inflated negative binomial regression, before and after adjustment for site, clinically relevant covariates determined according to the univariate results, and propensity score matching.ResultsA total of 196 patients were enrolled, 78 of whom died within 28 days. The number of ventilator-free days through day 28 did not differ significantly between the patients who received inhaled sedation for at least 24 h (n = 111) and those who received intravenous sedation only (n = 85), with medians of 0 (interquartile range [IQR] 0-8) and 0 (IQR 0-17), respectively (odds ratio for having zero ventilator-free days through day 28, 1.63, 95% confidence interval [CI], 0.91-2.92, p = 0.10). The incidence rate ratio for the number of ventilator-free days through day 28 if not 0 was 1.13 (95% CI, 0.84-1.52, p = 0.40). Similar results were found after multivariable adjustment and propensity matching.ConclusionThe use of inhaled sedation in COVID-19 ARDS was not associated with the number of ventilator-free days through day 28.
Project description:ObjectivesInhaled volatile anesthetics support management of status asthmaticus (SA), status epilepticus (SE), and difficult sedation (DS). This study aimed to evaluate the effectiveness, safety, and feasibility of using inhaled anesthetics for SA, SE, and DS in adult ICU and PICU patients.Data sourcesMEDLINE, Cochrane Central Register of Controlled Trials, and Embase.Study selectionPrimary literature search that reported the use of inhaled anesthetics in ventilated patients with SA, SE, and DS from 1970 to 2021.Data extractionStudy data points were extracted by two authors independently. Quality assessment was performed using the Joanna Briggs Institute appraisal tool for case studies/series, Newcastle criteria for cohort/case-control studies, and risk-of-bias framework for clinical trials.Data synthesisPrimary outcome was volatile efficacy in improving predefined clinical or physiologic endpoints. Secondary outcomes were adverse events and delivery logistics. From 4281 screened studies, the number of included studies/patients across diagnoses and patient groups were: SA (adult: 38/121, pediatric: 28/142), SE (adult: 18/37, pediatric: 5/10), and DS (adult: 21/355, pediatric: 10/90). Quality of evidence was low, consisting mainly of case reports and series. Clinical and physiologic improvement was seen within 1-2 hours of initiating volatiles, with variable efficacy across diagnoses and patient groups: SA (adult: 89-95%, pediatric: 80-97%), SE (adults: 54-100%, pediatric: 60-100%), and DS (adults: 60-90%, pediatric: 62-90%). Most common adverse events were cardiovascular, that is, hypotension and arrhythmias. Inhaled sedatives were commonly delivered using anesthesia machines for SA/SE and miniature vaporizers for DS. Few (10%) of studies reported required non-ICU personnel, and only 16% had ICU volatile delivery protocol.ConclusionsVolatile anesthetics may provide effective treatment in patients with SA, SE, and DS scenarios but the quality of evidence is low. Higher-quality powered prospective studies of the efficacy and safety of using volatile anesthetics to manage SA, SE, and DS patients are required. Education regarding inhaled anesthetics and the protocolization of their use is needed.
Project description:Objectives: The purpose of this study was to assess the impact of the injectable opioid drug shortage on analgesia and sedation management in the medical intensive care unit (MICU). Methods: A single-center, retrospective cohort study was conducted of mechanically ventilated patients during the injectable opioid shortage. Outcomes were compared between a cohort of patients during the intravenous (IV) opioid shortage (01/01/18-03/31/18) and a control cohort (01/01/17-03/31/17). Total IV opioids and alternative sedative administration were assessed. Richmond Agitation Sedation Score (RASS) and Clinical Pain Observation Score (CPOT) assessments were also evaluated. The primary outcome was percentage of RASS within goal. Secondary outcomes included duration of mechanical ventilation, hospital/ICU length of stay, and mortality. Results: One hundred patients were included (50 patients per cohort). In the shortage cohort, 23.2% fewer IV opioids were used (40 501.8 vs 52 713.8 oral morphine equivalents [OME]). No statistical differences were found in percentage of patients within goal RASS between the shortage and control (median 63.7% vs 74.8%; P = .094) or CPOT (median 49.7% vs 47.7%; P = .575). More patients received enteral opioids and propofol on day 1 in the shortage cohort when compared to the control (22% vs 4%; P = .007 and 76% vs 56%; P = .035) but there were no differences in benzodiazepine, dexmedetomidine, or antipsychotic use. No differences in mechanical ventilation, hospital/ICU length of stay, or mortality were found. Conclusions: Use of less IV opioids during the injectable opioid shortage did not affect achievement of goal RASS and CPOT scores or increase prescribing of sedative medications such as benzodiazepines in the MICU.
Project description:BackgroundThe COVID-19 pandemic has increased the number of patients in ICUs leading to a worldwide shortage of the intravenous sedative agents obligating physicians to find alternatives including inhaled sedation. Inhaled sedation in French ICU has been previously explored in 2019 (VOL'ICU study). This survey was designed to explore the use of inhaled sedation two years after our first survey and to evaluate how the COVID-19 pandemic has impacted the use of inhaled sedation.MethodsWe designed a national survey, contacting medical directors of French ICUs between June and October 2021. Over a 50-item questionnaire, the survey covered the characteristics of the ICU, data on inhaled sedation, and practical aspects of inhaled ICU sedation for both COVID-19 and non-COVID-19 patients. Answers were compared with the previous survey, VOL'ICU.ResultsAmong the 405 ICUs contacted, 25% of the questionnaires were recorded. Most ICU directors (87%) knew about the use of inhaled ICU sedation and 63% of them have an inhaled sedation's device in their unit. The COVID-19 pandemic increased the use of inhaled sedation in French ICUs. The main reasons said by the respondent were "need for additional sedative" (62%), "shortage of intravenous sedatives" (38%) and "involved in a clinical trial" (30%). The main reasons for not using inhaled ICU sedation were "device not available" (76%), "lack of familiarity" (60%) and "no training for the teams" (58%). More than 70% of respondents were overall satisfied with the use of inhaled sedation. Almost 80% of respondents stated that inhaled sedation was a seducing alternative to intravenous sedation for management of COVID-19 patients.ConclusionThe use of inhaled sedation in ICU has increased fastly in the last 2 years, and is frequently associated with a good satisfaction among the users. Even if the COVID-19 pandemic could have impacted the widespread use of inhaled sedation, it represents an alternative to intravenous sedation for more and more physicians.
Project description:BackgroundProcedural sedation and analgesia is an important part of pediatric emergency care, safe and clinically useful alternatives for adequate management are necessary. The objective of this clinical trial was to evaluate the non-inferiority of intranasal dexmedetomidine to nitrous oxide with respect to analgesia for a painful procedure in children 3-15 years of age.MethodsThis prospective, equally randomized, open-label, non-inferiority trial was conducted at a Pediatric Emergency Department. Previously healthy children 3-15 years of age, with an extremity fracture or luxation or a burn and requiring procedural sedation and analgesia were eligible. Patients were randomized to receive either intranasal dexmedetomidine or inhaled nitrous oxide. The primary outcome measure was highest pain level during the procedure, assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC). Mann-Whitney U test (continuous variables) and Fisher's test (categorical variables) were used for statistical analysis.ResultsThe highest FLACC was median 4 (IQR 3-6) with intranasal dexmedetomidine and median 4 (IQR 2-6) with nitrous oxide. The median of the difference between samples from each group for FLACC was 0 with 95%CI (0-1), thus intranasal dexmedetomidine was not inferior to nitrous oxide with respect to the level of pain during the procedure. The same method for procedural sedation and analgesia would be accepted by 52/74 (82.5%) children and 65/74 (91.5%) parents in the intranasal dexmedetomidine group respectively 59/74 (88.1%) versus 70/74 (94.6%) with nitrous oxide. No serious adverse events were reported.ConclusionsThe results of this trial support that intranasal dexmedetomidine is not inferior to 50% nitrous oxide in providing analgesia for a painful procedure in children 3-15 years of age and can be considered as an alternative to 50% nitrous oxide for procedural sedation and analgesia.Trial registrationEudraCT 201,600,377,317, April 20, 2017. https://eudract.ema.europa.eu/ .
Project description:IntroductionThe COVID-19 pandemic has renewed interest in the use of inhaled anaesthetics for sedation of ventilated critically ill patients. Preliminary data show that inhaled anaesthetics reduce lung inflammation, time to extubation and intensive care unit length of stay compared with intravenous sedatives. However, the impact of inhaled anaesthetics on cognitive and psychiatric outcomes is not well described in this setting. Randomised controlled trials are underway to establish if inhaled anaesthetics affect these and other patient and health system outcomes. Our aim is to summarise the known effects of inhaled sedatives on cognitive and psychiatric outcomes.Methods and analysisIn this systematic review, we will use MEDLINE, EMBASE, and PsycINFO to identify studies from 1970 to 2021 that assessed cognitive and psychiatric outcomes in critically ill adult patients sedated with inhaled anaesthetics. We will include case series, observational and cohort studies and randomised controlled trials. We will exclude case studies due to the heterogeneity of reporting in these studies. For randomised controlled trials comparing inhaled to intravenous sedation, we will report cognitive and psychiatric outcomes for both study arms. Studies will be selected based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Data will be extracted using a standardised data extraction tool by two independent reviewers. Studies will be assessed for bias using the Cochrane risk of bias tool for randomised controlled trials, or the Newcastle-Ottawa Scale for cohort and case-control studies. Findings will be reported according to outcome and descriptive statistics will be used to illustrate findings in a narrative fashion.Ethics and disseminationThe systematic review uses published data and therefore does not require ethics approval. Results will be disseminated via publication in peer-reviewed journals and presentation at conferences related to the field.Prospero registration numberCRD42021236455.
Project description:IntroductionSedation in mechanically ventilated adults in the intensive care unit (ICU) is commonly achieved with intravenous infusions of propofol, dexmedetomidine or benzodiazepines. Significant limitations associated with each can impact their usage. Inhaled isoflurane has potential benefit for ICU sedation due to its safety record, sedation profile, lack of metabolism and accumulation, and fast wake-up time. Administration in the ICU has historically been restricted by the lack of a safe and effective delivery system for the ICU. The Sedaconda Anaesthetic Conserving Device-S (Sedaconda ACD-S) has enabled the delivery of inhaled volatile anaesthetics for sedation with standard ICU ventilators, but it has not yet been rigorously evaluated in the USA. We aim to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared with intravenous propofol for sedation of mechanically ventilated ICU adults in USA hospitals.Methods and analysisINhaled Sedation versus Propofol in REspiratory failure in the ICU (INSPiRE-ICU1) is a phase 3, multicentre, randomised, controlled, open-label, assessor-blinded trial that aims to enrol 235 critically ill adults in 14 hospitals across the USA. Eligible patients are randomised in a 1.5:1 ratio for a treatment duration of up to 48 (±6) hours or extubation, whichever occurs first, with primary follow-up period of 30 days and additional follow-up to 6 months. Primary outcome is percentage of time at target sedation range. Key secondary outcomes include use of opioids during treatment, spontaneous breathing efforts during treatment, wake-up time at end of treatment and cognitive recovery after treatment.Ethics and disseminationTrial protocol has been approved by US Food and Drug Administration (FDA) and central (Advarra SSU00208265) or local institutional review boards ((IRB), Cleveland Clinic IRB FWA 00005367, Tufts HS IRB 20221969, Houston Methodist IRB PRO00035247, Mayo Clinic IRB Mod22-001084-08, University of Chicago IRB21-1917-AM011 and Intermountain IRB 033175). Results will be presented at scientific conferences, submitted for publication, and provided to the FDA.Trial registration numberNCT05312385.
Project description:We introduce a new agent-based model of opinion dynamics in which binary opinions of each agent can be measured and described regarding both pre- and post-influence at both of two levels, public and private, vis-à-vis the influence source. The model combines ideas introduced within the q-voter model with noise, proposed by physicists, with the descriptive, four-dimensional model of social response, formulated by social psychologists. We investigate two versions of the same model that differ only by the updating order: an opinion on the public level is updated before an opinion on the private level or vice versa. We show how the results on the macroscopic scale depend on this order. The main finding of this paper is that both models produce the same outcome if one looks only at such a macroscopic variable as the total number of the individuals with positive opinions. However, if also the level of internal harmony (viz., dissonance) is measured, then significant, qualitative differences are seen between these two versions of the model. All results were obtained simultaneously within Monte Carlo simulations and analytical calculations. We discuss the importance of our studies and findings from three points of view: the theory of phase transitions, agent-based modeling of social systems, and social psychology.