Clinical performance of early warning scoring systems for identifying sepsis among anti-hypertensive agent users.

BACKGROUND: Little is known about the accuracy of the quick Sequential Organ Failure Assessment (qSOFA) and the National Early Warning Score (NEWS) in identifying sepsis patients with a history of hypertension on anti-hypertensive agents, which affect vital signs as components of the scoring systems. We aimed to examine the ability of qSOFA and NEWS to predict sepsis among anti-hypertensive agent users by comparing them with non-users. METHODS: We retrospectively identified adult patients (aged ≥18years) with suspected infection who presented to an emergency department (ED) of a large tertiary medical center in Japan between April 2018 and March 2020. Suspected infection was defined based on the chief complaint of fever, high body temperature, or the clinical context on arrival at the ED. We excluded patients who had trauma or cardiac arrest, those who were transported to other hospitals after arrival at the ED, and those whose vital signs data were mostly missing. The predictive performances of qSOFA and NEWS based on initial vital signs were examined separately for sepsis, ICU admission, and in-hospital mortality and compared between anti-hypertensive agent users and non-users. RESULTS: Among 2900 patients with suspected infection presenting to the ED, 291 (10%) had sepsis, 1023 (35%) were admitted to the ICU, and 188 (6.5%) died. The prediction performances of qSOFA and NEWS for each outcome among anti-hypertensive agent users were lower than that among non-users (e.g., c-statistics of qSOFA for sepsis, 0.66 vs. 0.71, p = 0.07; and for ICU admission, 0.70 vs. 0.75, p = 0.01). For identifying sepsis, the sensitivity and specificity of qSOFA ≥2 were 0.43 and 0.77 in anti-hypertensive agent users and 0.51 and 0.82 in non-users. Similar associations were observed for identifying ICU admission and in-hospital mortality. Regardless of the use of anti-hypertensive agents, NEWS had better prediction abilities for each outcome than qSOFA. CONCLUSION: The clinical performance of qSOFA and NEWS for identifying sepsis among anti-hypertensive agent users was likely lower than that among non-users.

Midazolam and its effect on vital signs and behavior in children under conscious sedation in dentistry.

Midazolam is a short acting sedative with small number of adverse effects. Administered orally, it is currently the most common form of conscious sedation in children. The objective of this paper is to describe effect of midazolam administered to children during dental treatment on their vital signs, and to monitor changes in children's behavior. We described values of vital signs and behavior in 418 sedations conducted in 272 children between 1-12 years of age. To achieve the following results, we used data from 272 all first-time sedations. After administration of midazolam arterial blood pressure and blood oxygen saturation decreased by values which were not clinically significant. The heart rate increased, with values staying within the limits of physiological range. The speed of onset of midazolam's clinical effects depends on age and dose. The lower age and dose correlated with the higher behavior score. The effectiveness of midazolam treatment is 97.8 %. Unwillingness of child to receive midazolam is predictor for disruptive behavior during sedation. 1.8 % of all sedation cases showed paradoxical reactions. The administration of midazolam in dose of 0.5 mg per 1 kg of child's body weight is safe and could be recommended for dental treatment in pediatric dentistry.

Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.

Many clinical studies have evaluated the effect of probiotics, but only a few have assessed their dose effects on gut microbiota and host. We conducted a randomized, double-blind, controlled intervention clinical trial to assess the safety (primary endpoint) of and gut microbiota response (secondary endpoint) to the daily ingestion for 4 weeks of two doses (1 or 3 bottles/day) of a fermented milk product (Test) in 96 healthy adults. The Test product is a multi-strain fermented milk product, combining yogurt strains and probiotic candidate strains Lactobacillus paracasei subsp. paracasei CNCM I-1518 and CNCM I-3689 and Lactobacillus rhamnosus CNCM I-3690. We assessed the safety of the Test product on the following parameters: adverse events, vital signs, hematological and metabolic profile, hepatic, kidney or thyroid function, inflammatory markers, bowel habits and digestive symptoms. We explored the longitudinal gut microbiota response to product consumption and dose, by 16S rRNA gene sequencing and functional contribution by shotgun metagenomics. Safety results did not show any significant difference between the Test and Control products whatever the parameters assessed, at the two doses ingested daily over a 4-week-period. Probiotic candidate strains were detected only during consumption period, and at a significantly higher level for the three strains in subjects who consumed 3 products bottles/day. The global structure of the gut microbiota as assessed by alpha and beta-diversity, was not altered by consumption of the product for four weeks. A zero-inflated beta regression model with random effects (ZIBR) identified a few bacterial genera with differential responses to test product consumption dose compared to control. Shotgun metagenomics analysis revealed a functional contribution to the gut microbiome of probiotic candidates.

The Effect of Lavender Oil on Sleep Quality and Vital Signs in Palliative Care: A Randomized Clinical Trial.

BACKGROUND: This study was conducted to determine the effect of lavender oil on sleep quality and vital signs in palliative care patients. METHODS: We examined 68 patients in a palliative care unit. Vital signs of all the patients were assessed, and also their sleep quality was evaluated using the Richards-Campbell Sleep Questionnaire. Lavender was applied to patients in the experimental group. During the intervention, vital signs of the patients were monitored at 4-h intervals throughout the night, and sleep quality was evaluated during the morning. The same evaluation processes were performed for the control group. RESULTS: It was observed in the evaluation that lavender application did not affect the vital signs of the patients but it ensured a deeper sleep on the 2nd day after the intervention, facilitated their falling asleep and sleeping again when they were awakened and enhanced sleep quality (p < 0.05). Also, this application decreased the awakening frequency on the 1st and 2nd days and enhanced overall sleep quality (p < 0.05) after the intervention. CONCLUSIONS: Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.

The Effect of Inhaler Aromatherapy on Invasive Pain, Procedure Adherence, Vital Signs, and Saturation During Port Catheterization in Oncology Patients.

The study was conducted to evaluate the effect of inhaler aromatherapy on invasive pain, procedure adherence, vital signs, and saturation during port catheter insertion among patients diagnosed with cancer. The study was conducted in a nonrandomized controlled trial. Sixty patients including 30 patients in the intervention group and 30 patients in the control group, who were subjected with the same local anesthetic protocol, were included in the study. Aromatic mixture prepared by diluting orange, chamomile, and lavender oil in 70 mL distilled water was inhaled by the intervention group during the procedure. The data of the study were collected by using questionnaire, vital follow-up form, and visual analog scale. The patients in the intervention and control groups were similar in terms of sociodemographic and disease characteristics (P > .05). It was determined that inhaler aromatherapy applied to patients in the intervention group decreased pain experienced during the procedure and facilitated the procedure adherence (P < .05); however, it did not affect vital signs and saturation (P > .05). It can be recommended to administer inhaler aromatherapy with pharmacological therapies during catheterization procedure since it decreases invasive pain and facilitates the procedure adherence.

A randomized control trial using intraoperative dexmedetomidine during Roux-en-Y gastric bypass surgery to reduce postoperative pain and narcotic use.

BACKGROUND: Dexmedetomidine (DMET), a selective a2-adrenergic agonist, is an opioid-sparing adjuvant sedative that avoids respiratory depression and has been shown to be beneficial in bariatric surgery patients. Although benefit has been shown, prior studies have not evaluated the pain control effects of a single intraoperative bolus. OBJECTIVES: To evaluate the postoperative effects of a single intraoperative dose of DMET. SETTINGS: University Hospital, United States. METHODS: This is a prospective, randomized, double-blinded study registered with clinicaltrials.gov (#NCT02604940). Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery were randomized and given either a placebo or an intraoperative DMET bolus, where 1 mg/kg was delivered over 10 minutes at the time of surgical closure. Measured outcomes included the following: postoperative pain scores, patient-controlled analgesia (PCA) opioid consumption, PCA demand bolus attempts, duration of postanesthesia care unit (PACU) stay, and vital signs. Descriptive statistics were recorded as frequencies and compared using Χ2 analysis, and a Welch's 2-sample t test was used to compare continuous variables. RESULTS: Forty-six participants undergoing laparoscopic Roux-en-Y gastric bypass surgery were randomized into placebo (n = 20) or DMET (n = 26) groups. There were no statistical differences in age (45.1 versus 43.2 yr, P = .522), sex (80% versus 81% female, P = .948), and body mass index (46.1 versus 45.6 kg/m2, P = .818) between the 2 groups. There were no statistically significant differences in vital signs (heart rate, blood pressure, oxygen saturation, and respiration rate) between DMET and placebo groups in the preoperative and intraoperative period. During the initial 4 hours in the PACU postoperatively, mean heart rate (70 ± 12 versus 86 ± 14, P < .001), systolic blood pressure (107 ± 17 versus 148 ± 16, P < .001), and diastolic blood pressure (56 ± 15 versus 79 ± 13, P < .001) were significantly lower in the DMET-treated group compared with placebo. During the initial 4 hours in the PACU, mean self-reported pain scores were significantly lower in the DMET-treated group (3.6 ± 2.8) compared with the placebo group (6.7 ± 3; P = .005). The lower pain scores occurred with no significant difference in the mean opioid dosage received in the PACU between DMET-treated (2.66 ± 2.02 mg) and placebo (3.7 ± 2.3 mg; P = .09) groups. Also, there was no statistically significant difference in the total number of PCA attempts for opioids between the DMET-treated and placebo groups (P = .49). CONCLUSIONS: A single bolus of DMET (1 mg/kg delivered over 10 min) administered at the time of surgical closure did not reduce immediate PACU usage of opioids but significantly reduced reported pain scores and caused a significant decrease in the number of attempts made by patients; this is a trend of decreased attempts over time (P = .04) in the DMET group. The trend of the mean total medication used over time indicates that there is neither an increasing nor decreasing trend for the DMET group, but there is an increasing trend in the total used over time for the placebo group. There was no statistically or clinically significant bradycardia, hypotension, hypoxia, respiratory depression intraoperative duration, or PACU stay. Reduced single bolus dosing of DMET required for analgesia in bariatric surgery patients is optimal from physiologic, level of care, and cost perspectives.

Dexmedetomidine as an Additive to Local Anesthesia: A Step to Development in Dentistry.

PURPOSE: The study aimed to compare the effect of dexmedetomidine added to lidocaine against epinephrine added to lidocaine on local anesthetic potency and to look for future prospects of dexmedetomidine as an additive to local anesthesia in dentistry. MATERIALS AND METHODS: The study included 25 healthy volunteers in whom extraction of all first premolars was scheduled as part of their orthodontic treatment plan. In this split-mouth, double-blind, crossover, randomized controlled trial, patients were randomized into 2 groups: Group 1 received injection lidocaine plus dexmedetomidine, and group 2 was administered lidocaine plus epinephrine. Patients were assessed for the onset of action of anesthesia, duration of analgesia, pain perception, and vital signs. RESULTS: The mean values (±standard deviations) for the onset of anesthetic action in groups 1 and 2 were 113 ± 24.9 and 141 ± 34.8 seconds, respectively, for the mandible. For the maxilla, the mean values were 113 ± 24.9 seconds for group 1 and 165 ± 43.8 seconds for group 2. The duration of anesthesia was longer in group 1 (lidocaine plus dexmedetomidine), in which the requirement for the first analgesic on request was seen after a longer time interval, when compared with group 2 (lidocaine plus epinephrine). Pain perception elicited statistically significant results with less perception of pain in group 1 (lidocaine plus dexmedetomidine). The vital parameters remained stable, and the results were not statistically significant. CONCLUSIONS: In this study, we observed that the addition of dexmedetomidine to lidocaine for maxillary and mandibular nerve blocks significantly prolonged the block duration and shortened the onset of action, as well as improved postoperative analgesia in terms of the need for fewer analgesics in the postoperative period. Furthermore, the vital parameters remained stable and no complications were encountered. The findings were supportive of the use of dexmedetomidine as an adjunct to local anesthetics in dental procedures.

Effect of denaverine hydrochloride application to heifers on the APGAR score and lactate concentration in newborn calves.

OBJECTIVE: The aim of this study was to evaluate the influence of Denaverine hydrochloride (DNH) in heifers on calf vitality. MATERIAL AND METHODS: A total of 83 calvings with 38 female and 45 male calves were included in the study. Thirty minutes after onset of stage 2 of calving, 400 mg DNH or placebo (0.9% NaCl) were administered subcutaneously. If the calving procedure was not completed after 60 minutes, an extraction was conducted and pulling force was measured by using a digital force gauge. Directly after parturition, vitality of calves was evaluated using a modified APGAR score. Additionally, lactate concentration in blood from Vena auricularis was measured with a handheld measuring device (lactate scout). RESULTS: No effect of treatment was observed on APGAR score and lactate concentration. CLINICAL RELEVANCE: Denaverine hydrochloride is a regularly used substance in obstetrics in veterinary medicine in many European countries. We could not confirm our hypotheses that treating heifers with DNH has a positive effect on calf vitality evaluated by APGAR score and lactate concentration in blood.

Recognition of Sympathetic Crashing Acute Pulmonary Edema (SCAPE) and use of high-dose nitroglycerin infusion.

Sympathetic Crashing Acute Pulmonary Edema (SCAPE), or flash pulmonary edema, is the extreme end of the acute pulmonary edema spectrum. A sympathetic surge occurs as a result of decreased systemic perfusion resulting in further increases in afterload, causing the patient to decompensate. Patients can decompensate quickly, therefore patients require rapid interventions. The use of high-dose nitroglycerin (HDN) has been a topic of interest as it is believed to achieve preload and afterload reduction. However, its use continues to be controversial due to concerns of drug induced hypotension, syncope or paresthesia. Although there are Free Open Access Medical Education (FOAM) based podcasts as well as few studies to suggest the use of HDN, the evidence is limited by statistical flaws, incomplete dosing parameters and inconsistent methods of administration. In order to address these limitations, a protocol at our ED was created to ensure the safe and effective use of HDN. Here, we present a case of HDN use for the management of SCAPE based on this protocol.

Vital Signs as Predictor Factors of Intravenous Immunoglobulin Resistance in Patients With Kawasaki Disease.

Kawasaki disease (KD) is the most common cause of acquired heart disease in children. Intravenous immunoglobulin (IVIG) may significantly lower the frequency of coronary artery complications. However, some patients do not respond to initial therapy and are at higher risk of developing coronary artery lesion. A retrospective analysis of data from 419 KD patients was performed. The patients were divided into IVIG responders (n = 318) and IVIG nonresponders (n = 101). Multivariate logistic regression analysis revealed neutrophil percentage, albumin, aspartate aminotransferase, heart rate, and body temperature were independent predictors of IVIG resistance. We generated a predictive scoring system by assigning 1 point for the presence of these parameters (neutrophil >80%, albumin <3.4 g/dL, aspartate aminotransferase >100 IU/L, heart rate >146 bpm, and body temperature >38.8°C). This scoring system had a sensitivity of 76.2% and specificity of 64.8%, and a positive predictive value of 40.1% and a negative predictive value of 89.4%. Vital signs may be helpful to detect KD patients with IVIG resistance.

Risk Factor for Vital Signs Fluctuation during Colonoscopy under Conscious Sedation Consisting of Midazolam and Meperidine.

BACKGROUND: Sedatives or analgesics are widely used to relieve a patient's discomfort during colonoscopy (CS). Although cardiopulmonary adverse events are sometimes experienced during the examination, the risk factors for vital signs fluctuation (VSF) have not been fully elucidated. This study thus aimed to identify the risk factors for VSF during the examination, as well as to evaluate the frequency and the degree of VSF. SUMMARY: A total of 755 consecutive subjects who received CS under endoscopist-administrated sedation using midazolam, meperidine, or combination of both were retrospectively analyzed. We assessed the distribution of vital signs during the procedure and frequency of VSF. To identify independent risk factors, we analyzed the association between VSF and subjects' characteristics and procedure information using the multivariate logistic regression model. Consequently, VSF was observed in 17% of all; hypotension and oxygen desaturation was observed in 13 and 5%, respectively. However, we could achieve the purpose of all procedure and, no one required hospitalization or extension of hospital stay. Multivariate analysis revealed that age (OR 1.05 [95% CI 1.04-1.07]), being female (OR 1.78 [95% CI 1.19-2.70]), and use of midazolam (OR 5.06 [95% CI 3.18-8.08]) were independent risk factors for VSF.

Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study.

OBJECTIVE: To evaluate safety (primary objective) and efficacy of increasing doses (400 U up to 800 U) of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for patients with limb spasticity. METHODS: In this prospective, single-arm, dose-titration study (NCT01603459), patients (18-80 years) with spasticity due to cerebral causes, who were clinically deemed to require total doses of 800 U incobotulinumtoxinA, received 3 consecutive injection cycles (ICs) with 400 U, 600 U, and 600-800 U incobotulinumtoxinA, respectively, each followed by 12-16 weeks' observation. Outcomes included adverse events (AEs), antibody testing, Resistance to Passive Movement Scale (REPAS; based on the Ashworth Scale), and Goal Attainment Scale. RESULTS: In total, 155 patients were enrolled. IncobotulinumtoxinA dose escalation did not lead to an increased incidence of treatment-related AEs (IC1: 4.5%; IC2: 5.3%; IC3: 2.9%). No treatment-related serious AEs occurred. The most frequent AEs overall were falls (7.7%), nasopharyngitis, arthralgia, and diarrhea (6.5% each). Five patients (3.2%) discontinued due to AEs. No patient developed secondary nonresponse due to neutralizing antibodies. Mean (SD) REPAS score improvements from each injection to 4 weeks postinjection increased throughout the study (IC1: -4.6 [3.9]; IC2: -5.9 [4.2]; IC3: -7.1 [4.8]; p < 0.0001 for all). The proportion of patients achieving ≥3 (of 4) treatment goals also increased (IC1: 25.2%; IC2: 50.7%; IC3: 68.6%). CONCLUSION: Escalating incobotulinumtoxinA doses (400 U up to 800 U) did not compromise safety or tolerability, enabled treatment in a greater number of muscles/spasticity patterns, and was associated with increased treatment efficacy, improved muscle tone, and goal attainment. CLINICALTRIALSGOV IDENTIFIER: NCT01603459. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that, for patients with limb spasticity, escalating incobotulinumtoxinA doses (400 U up to 800 U) increases treatment efficacy without compromising safety or tolerability.

Developing an objective method for analyzing vital signs changes in neonates during general anesthesia.

BACKGROUND: Commonly used general anesthetics are considered to be neurotoxic to the developing rodent brain, leading to poor long-term outcome. However, it is unclear whether these rodent studies can be extrapolated to the human neonate. Given that anesthesia for urgent neonatal surgery cannot be avoided, it is vitally important to assess other factors that may impact neurological outcome following anesthesia and surgery. OBJECTIVE: The purpose of this study is to identify thresholds for detecting vital sign deviations, which may have the potential for affecting neurological outcome following anesthesia and surgery in neonates. These data may be suitable to identify targets for prospective quality improvement projects and guide future research for strategies to reduce detrimental neurocognitive outcomes. METHODS: A retrospective analysis of vital sign data was performed for neonates (age ≤28 days), undergoing noncardiac surgery over a 4-year period (2010-2013). Thresholds for detecting bradycardia, tachycardia, hypothermia, hyperthermia, hypertension, hypotension, hypocarbia, hypoxemia, significant changes in mean arterial blood pressure, and periods of high inspired oxygen concentration, were proposed. Selected chart review, to identify additional risk factors, and identify sources of data artifact, was performed for 224 cases. RESULTS: Data from 435 procedures in neonates, with median (IQR [range]) ages of 6 (2-16 [0-28]) days were available for analysis. Five (3-6 [0-12]) rule deviations per case were observed; only 11 cases had no rule deviations. Hypothermia was observed in 285/435 (70%), moderate hypocapnia in 298/430 (69%), and severe hypotension in 270/435 (62%) cases. CONCLUSION: An objective method of comparing cases has been created with a method to automatically identify neonatal vital sign deviations. With further validation the method has the potential to be a powerful tool to drive future quality improvement projects in neonatal anesthesia.

Long-term safety of glycopyrrolate: A randomized study in patients with moderate-to-severe COPD (GEM3).

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in the United States. Long-acting muscarinic antagonists (LAMAs) are a class of medications used as maintenance therapy for COPD. The GEM3 (Glycopyrrolate Effect on syMptoms and lung function) study assessed the long-term safety and efficacy of a LAMA, glycopyrrolate (GLY) 15.6 µg twice daily (b.i.d.), compared with an approved long-acting ß2-agonist (LABA), indacaterol (IND) 75 µg once daily (q.d.) in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation. METHODS: This 52-week, multicenter, double-blind, parallel-group study randomized patients (1:1) of the United States to receive GLY 15.6 µg b.i.d. or IND 75 µg q.d. both delivered via the Neohaler(®) device. The primary objective was to assess the safety and tolerability in terms of adverse event (AE) reporting rates over 52 weeks. Safety was also determined by evaluating multiple secondary endpoints, including vital signs, electrocardiograms (ECGs), and time to first moderate or severe exacerbation. Efficacy-related secondary endpoints included pre-dose forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). RESULTS: Of the 511 randomized patients (GLY, n = 254; IND, n = 257), 81.6% completed the study. The overall incidences of AEs (GLY, 77.3%; IND, 77.0%) and serious AEs (GLY, 13.1%; IND, 13.3%) were comparable between the groups. The incidence of major adverse cardiovascular events was low and comparable between the groups. No clinically relevant differences for vital signs or ECG parameters were observed between the treatment groups. The three sudden deaths reported within 30 days of the treatment (GLY, n = 2; IND, n = 1) were adjudicated as unrelated to the study medication. In terms of efficacy, GLY 15.6 µg b.i.d. showed improvements in pre-dose FEV1 and FVC from baseline, which was comparable to those with IND 75 µg q.d., with no statistically significant differences. No significant differences were observed between the treatment groups in the time to first moderate or severe COPD exacerbation. CONCLUSION: GLY 15.6 µg b.i.d. showed a long-term safety profile comparable to that of IND 75 µg q.d. and provided rapid and sustained bronchodilation over 52 weeks in patients with COPD with moderate-to-severe airflow limitation. CLINICAL TRIAL REGISTRATION NUMBER: NCT01697696.

Trends in vital signs and routine biomarkers in patients with sepsis during resuscitation in the emergency department: a prospective observational pilot study.

OBJECTIVES: Sepsis lacks a reliable and readily available measure of disease activity. Thereby, it remains unclear how to monitor response to treatment. Research on numerous (new) biomarkers associated with sepsis provided disappointing results and little is known about changes in vital signs during sepsis resuscitation. We hypothesised that trends in vital signs together with routine biomarker levels during resuscitation might provide information about the response to treatment at a very early stage of sepsis in the emergency department (ED). We therefore explore trends in vital signs and routine biomarker levels during sepsis resuscitation in the ED. DESIGN: Prospective observational pilot study. SETTING: ED of a tertiary care teaching hospital. PARTICIPANTS: 99 Adult non-trauma patients with suspected infection and 2 or more systemic inflammatory response syndrome criteria admitted to the ED. PRIMARY AND SECONDARY OUTCOME MEASURES: Vital signs and biomarker levels at admittance (T0) and after 3 h in the ED (T1). RESULTS: In total, data of 99 patients were analysed. Of these patients, 63 presented with sepsis, 30 with severe sepsis and 6 with septic shock. All vital signs decreased, except for peripheral oxygen saturation which increased. Almost all routine biomarker levels decreased during resuscitation, except for C reactive protein, bands, potassium, troponin T and direct bilirubin which remained stable. Sodium, chloride and N-terminal prohormone of brain natriuretic peptide increased slightly. CONCLUSIONS: Vital signs and biomarker levels showed descending trends during resuscitation, except for parameters directly affected by treatment modalities. Despite these trends, most patients improved clinically. Trends in vital signs and routine biomarkers might be helpful in predicting clinical course and response to treatment in patients with sepsis during early resuscitation.

Computational Depth of Anesthesia via Multiple Vital Signs Based on Artificial Neural Networks.

This study evaluated the depth of anesthesia (DoA) index using artificial neural networks (ANN) which is performed as the modeling technique. Totally 63-patient data is addressed, for both modeling and testing of 17 and 46 patients, respectively. The empirical mode decomposition (EMD) is utilized to purify between the electroencephalography (EEG) signal and the noise. The filtered EEG signal is subsequently extracted to achieve a sample entropy index by every 5-second signal. Then, it is combined with other mean values of vital signs, that is, electromyography (EMG), heart rate (HR), pulse, systolic blood pressure (SBP), diastolic blood pressure (DBP), and signal quality index (SQI) to evaluate the DoA index as the input. The 5 doctor scores are averaged to obtain an output index. The mean absolute error (MAE) is utilized as the performance evaluation. 10-fold cross-validation is performed in order to generalize the model. The ANN model is compared with the bispectral index (BIS). The results show that the ANN is able to produce lower MAE than BIS. For the correlation coefficient, ANN also has higher value than BIS tested on the 46-patient testing data. Sensitivity analysis and cross-validation method are applied in advance. The results state that EMG has the most effecting parameter, significantly.

The pharmacokinetic profile, tolerability and safety of the iodinated, non-ionic, dimeric contrast medium Iosimenol 340 injection in healthy human subjects.

BACKGROUND: Iosimenol 340 injection is a new isotonic iodinated contrast medium for X-ray angiography. PURPOSE: To investigate the pharmacokinetics and biotransformation, tolerability, and safety of Iosimenol 340 in healthy human subjects. MATERIAL AND METHODS: Twenty-four subjects were enrolled and randomized to receive either Iosimenol 340 (0.5, 1.5 or 3.0 mL/kg) or placebo (0.9% saline). In each dosing group, six subjects received Iosimenol 340 and two subjects received placebo. Safety was assessed by physical examination, vital signs, electrocardiography, and laboratory tests. Adverse events were recorded throughout the study up to 14 days after dosing. Blood samples were collected from 10 min before until 48 h after the start of dosing and urine samples were collected from 15 min before until 96 h after the start of dosing. Iosimenol was quantified in plasma and urine by measuring iodine concentrations with X-ray fluorescence. High-performance liquid chromatography was used to assess iosimenol biotransformation. RESULTS: Mean half-lives (mean ± standard deviation [SD]) of iosimenol were 0.17 ± 0.08 h (10.2 ± 4.8 min) and 2.01 ± 0.32 h for distribution and terminal elimination phases, respectively. The apparent volume of distribution was 0.27 ± 0.05 L/kg, indicating distribution to the extracellular fluid volume. Iosimenol was excreted within 24 h without any sign of metabolic transformation. Thirty-two adverse events were observed in 14 subjects. All were mild or moderate, and were transient in nature. CONCLUSION: Iosimenol was not metabolized, had a distribution volume corresponding to the extracellular space, and was rapidly excreted through the kidneys by glomerular filtration. The area under the plasma concentration curve and the peak plasma concentration was proportional to dose, while clearance was independent of dose. Iosimenol 340 was well tolerated.

Comparison of the effects of lidocaine and fentanyl in epidural anesthesia in dogs.

The study included 12 clinically healthy, adult male dogs of various breeds, admitted to our clinic for castration. After general anesthesia with sevoflurane, we administered epidural fentanyl (1 mcg/kg) to fentanyl group, while lidocaine group was given Lidocaine (3 mg/kg) through epidural administration. When hemodynamic parameters were stabilized, first measurements were recorded at minutes 0, 15, 30, 60 in both groups, which included Heart Rate (HR), body temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), sodium (Na+), potassium (K+), glucose (GLC), and hemoglobin (HB) measurements. In addition, serum samples were obtained from arterial blood at the same measurement times, and pH, pO2, pCO2, HCO3, %O2 Saturation, BE levels were measured. For hematological analysis, WBC, RBC, HCT, THR counts were performed. For serum biochemical analysis, venous blood samples were collected at minutes 0 and 60 and CK, TP, UREA, ALT, AST, ALB, GGT, CRE, CK-MB parameters were assessed using auto-analyzer. Moreover, cortisol levels were measured in the samples collected at minutes 0, 30, and 60.Mean arterial blood pressure values measured at minutes 15, 30 and 60 were found significantly lower in the fentanyl group (p<0.01). In conclusion, we suggest that epidural anesthesia with lidocaine and fentanyl can provide an effective and safe option in high-risk groups (Tab. 5, Fig. 1, Ref. 24).

Effects of acute administration of selective serotonin reuptake inhibitors on sympathetic nerve activity.

Serotonergic mechanisms have an important function in the central control of circulation. Here, the acute effects of three selective serotonin (5-HT) reuptake inhibitors (SSRIs) on autonomic and cardiorespiratory variables were measured in rats. Although SSRIs require 2-3 weeks to achieve their full antidepressant effects, it has been shown that they cause an immediate inhibition of 5-HT reuptake. Seventy male Wistar rats were anesthetized with urethane and instrumented to record blood pressure, heart rate, renal sympathetic nerve activity (RSNA), and respiratory frequency. At lower doses, the acute cardiovascular effects of fluoxetine, paroxetine and sertraline administered intravenously were insignificant and variable. At middle and higher doses, a general pattern was observed, with significant reductions in sympathetic nerve activity. At 10 min, fluoxetine (3 and 10 mg/kg) reduced RSNA by -33 ± 4.7 and -31 ± 5.4%, respectively, without changes in blood pressure; 3 and 10 mg/kg paroxetine reduced RSNA by -35 ± 5.4 and -31 ± 5.5%, respectively, with an increase in blood pressure +26.3 ± 2.5; 3 mg/kg sertraline reduced RSNA by -59.4 ± 8.6%, without changes in blood pressure. Sympathoinhibition began 5 min after injection and lasted approximately 30 min. For fluoxetine and sertraline, but not paroxetine, there was a reduction in heart rate that was nearly parallel to the sympathoinhibition. The effect of these drugs on the other variables was insignificant. In conclusion, acute peripheral administration of SSRIs caused early autonomic cardiovascular effects, particularly sympathoinhibition, as measured by RSNA. Although a peripheral action cannot be ruled out, such effects are presumably mostly central.