BackgroundDexmedetomidine (DEX) is a centrally acting alpha-2-adrenoceptor agonist that has potential in the management of alcohol withdrawal syndrome (AWS) owing to its ability to produce arousable sedation and to inhibit the adrenergic system without respiratory depression. The objective of this randomized controlled study was to evaluate whether addition of DEX to benzodiazepine (BZD) therapy is effective and safe for AWS patients in the intensive care unit (ICU).MethodsEligible participants were randomly assigned to intervention (Group D; n = 36) or control (Group C; n = 36). In Group D, DEX infusion was started at a dose of 0.2–1.4 μg/kg/h and titrated to achieve the target sedation level (–2 to 0 on the Richmond Agitation Sedation Scale (RASS)) with symptom-triggered BZD (10 mg diazepam bolus) was used as needed. Patients in Group C received only symptom-triggered 10 mg boluses of diazepam. The primary efficacy outcomes were 24-h diazepam consumption and cumulative diazepam dose required over the course of the ICU stay; secondary outcomes included length of ICU stay, sedation and communication quality and haloperidol requirements.ResultsMedian 24-h diazepam consumption during the study was significantly lower in Group D (20 vs. 40 mg, p < 0.001), as well as median cumulative diazepam dose during the ICU stay (60 vs. 90 mg, p < 0.001). The median percentage of time in the target sedation range was higher in Group D (median 90 % (90–95) vs. 64.5 % (60–72.5; p < 0.001). DEX infusion was also associated with better nurse-assessed patient communication (<0.001) and fewer patients requiring haloperidol treatment (2 vs. 10 p = 0.02). One patient in Group D and four in Group C were excluded owing to insufficient control of AWS symptoms and use of additional sedatives (p = 0.36). There were no severe adverse events in either group. Spontaneous breathing remained normal in all patients. Bradycardia was a common adverse event in Group D (10 vs. 2; p = 0.03).ConclusionsDEX significantly reduced diazepam requirements in ICU patients with AWS and decreased the number of patients who required haloperidol for severe agitation and hallucinations. DEX use was also associated with improvement in diverse aspects of sedation quality and the quality of patient communication.Trial registration: ClinicalTrials.gov: NCT02496650
Three additional sub-states: without exacerbation, mild and severe exacerbation were considered. The effectiveness of treatment options and utilities for each health state were taken from the literature. Only direct health care costs were considered. Disease management and exacerbation costs were obtained from the literature. Drug costs were calculated based on ex-factory prices with mandatory 7.5% rebate. All costs were updated to € 2012. A 3% annual discount rate on costs and health outcomes was applied. Incremental ratios in terms of cost per life-year gained (LYG) and cost per quality-adjusted life-year gained (QALY) of the most effective therapy versus the comparator were calculated. One-way sensitivity analyses were performed modifying the following parameters: time horizon (10 years, lifetime), discount rate (0%, 5%), drug costs (±10%, ±20%) and utilities (±10%). Probabilistic sensitivity analysis (PSA) was also performed. Results: At 5 years, glycopyrronium bromide accounted a total cost of € 2,225.18 compared to € 2,374.81 accounted for tiotropium bromide. Glycopyrronium bromide yielded higher health benefits (4,321 LYG and 3,388 QALY) than tiotropium bromide (4,315 LYG and 3,377 QALY). In all oneway sensitivity analyses performed and in 100% of PSA simulations (1,000 iterations), glycopyrronium bromide compared to tiotropium bromide remained as a dominant strategy. ConClusions: Glycopyrronium bromide therapy in COPD patients is associated to less costs and higher health benefits than tiotropium in Spain.
Objective ‒ to compare the incidence of complications and the main treatment outcomes of non-invasive mechanical ventilation (NIV) with a helmet versus NIV with a full face mask.Materials and methods. A monocentric randomized open-labeled controlled clinical trial. Patients with exacerbation of chronic obstructive pulmonary disease (COPD) with signs of respiratory failure were randomized to receive NIV through a mask or helmet. The study included 59 patients who were randomized into two groups: NIV through helmet (n = 29) or mask (n = 30). The average age of the patients was (59.24 ± 14.20) and (59.06 ± 15.90) years, respectively. In both groups men predominated ‒ 23 (79 %) and 27 (90 %) respectively. Ventilation was performed with a Draeger Carina apparatus in pressure support (PS) mode. The primary endpoint was the cumulative incidence of NIV complications. Secondary endpoints were PaO2/FiO2 ratio, tolerance to therapy, frequency of intubations, duration of stay in the intensive care unit (ICU), and ICU mortality. A total of 59 patients were involved in the study.Results. The complication rate was lower in the helmet group (10 % (n = 3) versus 43 % (n = 13), p = 0.004) and the PaO2/FiO2 ratio was higher at the first hour and at the end of NIV (253.14 ± 64.74) mm Hg versus (216.06 ± 43.86) mm Hg and (277.07 ± 84.89) mmHg versus (225.81 ± 63.64) mm Hg, p = 0.013 and p = 0.012) compared with NIV through a full face mask. More patients noted excellent helmet tolerance than masks at the 4th hour of therapy (24 (83 %) versus 14 (47 %), p = 0.004) and at the end of ventilation (69 % (20/29) versus 30 % (9/30), p = 0.03). One patient was unable to continue therapy due to mask intolerance. Differences in intubation rates, length of ICU stay, and mortality were statistically insignificant (p = 0.612, p = 0.100, p = 1.000 respectively).Conclusions. NIV through a helmet can reduce the incidence of complications and increase the PaO2/FiO2 ratio, as well as improve tolerance compared to NIV through a face mask in patients with exacerbation of COPD. A larger scale of study is needed to establish the effect of interface choice on ICU mortality, time spent in ICU, and frequency of intubation.
На цiо нал ьн ий мед ичн ий ун iве рси тет iмен i О.О. Бог омо ль ця, Ки їв Метa-в из начити е фе кт ив нiст ь та без печн iсть про по фолу, де ксмедето мiдину т а їх ко мб iн а ц iю д ля се да цi ї па цi єн т iв з т яж ки м ст а н о м в i дм iн и а л ко го л ю у в i дд iл е н н i iнтенсивної терапiї. Матерi али та методи. У дослiдження залучено 210 пацiєнтiв, як их р о з п одi лил и н а чо т ир и гр упи-гр уп а д е кс мед ет о м iдi н у, пр о по ф олу, де ксм ед е т о м i д i н у т а п р о по ф о л у i к о н т р о л ь н а. Тр и в а л iс т ь го сп i т а л iз а ц i ї у в i д д i ле н н я iнт енсив ної т ерапiї ст ановила вiдповiдно 5 1 год [46-75], 68 го д [4 8-98], 68 год [48-78 ] та 92 год [70-10 2]. Групи дост ов iр но не в iдрiз нялися за частот ою ускладне но го п е р е б i г у с т а н у в i дм i н и а л к о го л ю т а л е т а л ь н i с т ю. Ре зу л ь т а т и. С п о жи в а н н я дiа з е па му т а кiлькiст ь па цiєн тiв , якi пот р е був а ли пр из н аче н н я га ло пе р идолу, були д о с т о в i р н о м е н ш и м и , а я к i ст ь с е д а ц i ї т а ко м у н i к а ц i ї з па ц i є н т а ми-з н а ч н о к р а щ и м и в г р у п а х д о с л i д ж е н н я п о р i в н я н о з к о н т р о л ь н о ю г р у п о ю. В и с н ов о к. Д е к с м е д е т о м i д и н , п р о п о ф о л т а ї х к о м б i н а ц i я є е ф е к т и в н и м и т а б е з п е ч н и м и д л я с е д а ц i ї п а ц i є н т i в з i с т а н о м в i д м i н и а л к о г о л ю у в i д д i л е н н i i н т е н с и в н о ї т е р а п i ї .
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.