Comparison of Hemodynamic Changes in Unilateral Spinal Anesthesia Versus Epidural Anesthesia Below the T10 Sensory Level in Unilateral Surgeries: a Double-Blind Randomized Clinical Trial.

BACKGROUND: Unilateral spinal anesthesia is used to limit the spread of block. The aim of the present study was to compare hemodynamic changes and complications in unilateral spinal anesthesia and epidural anesthesia below the T10 sensory level in unilateral surgeries. MATERIALS AND METHODS: In this double-blind randomized clinical trial in total 120 patients were randomly divided into a unilateral spinal anesthesia group (Group S) and an epidural anesthesia group (Group E). Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rates were measured before and immediately after the administration of spinal or epidural anesthesia and then at 5-, 10-, 15-, 20-, 25-, and 30-min intervals. The rates of prescribed ephedrine and intraoperative respiratory arrest were recorded, in addition to postoperative nausea and vomiting, puncture headaches, and back pain during the first 24 h after the surgery. RESULTS: SBP, DBP, and MAP values initially showed a statistically significant downward trend in both groups (p = 0.001). The prevalence of hypotension in Group S was lower than in Group E, and the observed difference was statistically significant (p < 0.0001). The mean heart rate change in Group E was greater than in Group S, although the difference was not statistically significant (p = 0.68). The incidence of prescribed ephedrine in response to a critical hemodynamic situation was 5.1% (n = 3) and 75% (n = 42) in Group S and Group E, respectively (p = 0.0001). The incidence of headaches, back pain, and nausea/vomiting was 15.3%, 15.3%, and 10.2% in Group S and 1.8%, 30.4%, and 5.4% in Group E (p = 0.017, 0.07, and 0.49, respectively). CONCLUSION: Hemodynamic stability, reduced administration of ephedrine, a simple, low-cost technique, and adequate sensory and motor block are major advantages of unilateral spinal anesthesia.

History full circle: 'Novel' sympathomimetics in supplements.

Since the banning of ephedrine in over-the-counter nutritional supplements a decade ago, a plethora of untested and/or unsafe sympathomimetic stimulants have taken its place. This paper argues that these 'novel' stimulants in supplements recapitulate the work of synthetic chemists at commercial pharmaceutical firms during the 1930s and 1940s, all seeking substitutes for recently successful products based on ephedrine and amphetamine. Copyright © 2015 John Wiley & Sons, Ltd.

Assessment of an updated double-vasopressor automated system using Nexfin for the maintenance of haemodynamic stability to improve peri-operative outcome during spinal anaesthesia for caesarean section.

Hypotension occurs commonly during spinal anaesthesia for caesarean section, associated with maternal and fetal adverse effects. We developed a double-vasopressor automated system with a two-step algorithm and continuous non-invasive haemodynamic monitoring using the Nexfin device. The system delivered 25 µg phenylephrine every 30 s when systolic blood pressure was between 90% and 100% of baseline, or 2 mg ephedrine at this blood pressure range and heart rate < 60 beats.min(-1) ; and 50 µg phenylephrine or 4 mg ephedrine when systolic blood pressure was < 90% of baseline with the same heart rate criterion. Fifty-seven women received standardised spinal anaesthesia. Twenty-seven (47.4%) had at least one reading of hypotension defined as systolic blood pressure < 80% baseline. Systolic blood pressure was within 20% of the baseline in a mean (SD) of 79.8 (20.9)% of measurements. Fifty-three (93.0%) women required phenylephrine before delivery while 10 (17.5%) required ephedrine. Six women (10.5%) experienced nausea and three (5.3%) vomited. The system was able to achieve a low incidence of maternal hypotension with good maternal and fetal outcomes.

[Economic impact of strategies using ephedrine prefilled syringes]. / Impact économique des stratégies de recours à l'éphédrine en seringues préremplies.

OBJECTIVES: Ephedrine is an emergency drug available in ampules and syringes need to be prepared in advance according to one of two strategies in our establishment: strategy 1 (S1: 1 ampule per patient) and strategy 2 (S2: 1 ampule per operating room). There are also prefilled syringes. Because of their high cost and conflicting results in the literature, we assessed the economic interest of using prefilled syringes compared with strategies S1 and S2. TYPE OF STUDY: This was a prospective observational study. PATIENTS AND METHODS: The consumption of ephedrine was recorded over two periods of 14 days: P1 with syringes prepared in advance according to S1 or S2 and P2 with the on-demand use of prefilled syringes. RESULTS: The cost of a syringe of ephedrine prepared in advance (nurse time preparation included) was evaluated at €1.65 vs. €3.57 for a prefilled syringe. In operating rooms using S1, the use of prefilled syringes reduced overall the cost per patient about €1.22 and global annual costs by 72% (€2830), while the decrease was about €0.32 for the cost per patient and about 47% (€2760) for global annual costs for operating rooms using S2. CONCLUSION: The interest of our study is that we investigated different supply strategies for ephedrine within a large number of operating rooms. In our establishment, it was decided to use prefilled syringes in operating rooms that used S1. As well as the economic interest, prefilled syringes contributed to improved safety and saved nursing time.

[Crisis management during regional anesthesia including peripheral nerve block, epidural anesthesia and spinal anesthesia].

Crisis management during regional anesthesia including peripheral nerve block, epidural anesthesia and spinal anesthesia was reviewed. Common crisis which is encountered during regional anesthesia includes toxic reaction to local anesthetic drugs, allergic reaction induced by local anesthetic drugs, reaction induced by epinephrine, nerve injury, hematoma etc. Concerning peripheral nerve block, crisis encountered during brachial plexus block, interscalene block and supraclavicular block used for surgical operation of upper extremity was discussed. On the other hands, there are various common crises encountered during epidural anesthesia and spinal anesthesia. These crises include hypotension, bradycardia, total spinal anesthesia, postspinal headache and infection, and hematoma in the spinal canal. Especially, epidural hematoma and epidural abcess have possibility to cause nerve defect symptoms such as motor paralysis and sensory disturbance if appropriate treatment was not started in early stage. Moreover crisis such as cauda equina syndrome and anterior spinal cord syndrome have possibility to remain permanent and hard to cure. We anesthesiologists should make efforts to prevent crisis, to detect crisis in early stage, and to treat it in early stage.

[Use of ephedrine prefilled syringes reduces anesthesia costs]. / Réduction des coûts grâce à l'utilisation des seringues préremplies d'éphédrine.

OBJECTIVE: The aim of the present study was to compare the consumption and cost of ephedrine in parturients with respect to two packagings: ampoules and prefilled syringes. STUDY DESIGN: Prospective observational study in a French university obstetrical unit. PATIENTS AND METHODS: Assessing the consumption and cost of ephedrine during two consecutive periods of 14 days: use of ampoules for period 1 (P1) versus use of prefilled syringes for period 2 (P2). Consumption was daily evaluated. The costs (ampoules and consumable supplies for P1 and prefilled syringes for P2) were calculated on the basis of the price list given by our institutional pharmacy. The number of parturients and the anaesthetic techniques which were performed were prospectively recorded. RESULTS: One hundred and thirteen parturients were managed for the present study. The number of parturients and the anaesthetic care were similar between the two periods. In contrast, 155 ampoules were used for P1 versus 45 prefilled syringes for P2 (p<0.0001). The cost per parturient was 3.1 euro for P1 versus 2.6 euro for P2, i.e. 0.5 euro was saved for each parturient. CONCLUSION: The results of the present study show that the use of prefilled syringes reduces significantly the wastage of ephedrine, allowing subsequent cost minimization in obstetrical anaesthesia.

[Assessment of the clinical efficacy and safety of epinastine plus pseudoephedrine vs loratadine plus pseudoephedrine in perennial allergic rhinitis]. / Evaluación de la eficacia y seguridad clínica de epinastina más pseudoefedrina vs loratadina más pseudoefedrina en rinitis alérgica perenne.

BACKGROUND: Several drugs for the treatment of perennial allergic rhinitis and its symptoms have been investigated since some years ago. These drugs are: steroidal-type immunoregulators, immunotherapy and antihistamines. Because of first generation of the last ones originated several side effects, pharmacological research was oriented to the search of formulas with the same of higher efficacy, but with fewer effects on central nervous system. OBJECTIVE: To compare the efficacy and safety of epinastine 10 mg plus pseudoephedrine 120 mg vs loratadine 5 mg plus pseudoephedrine 120 mg, twice a day, in the treatment of perennial allergic rhinitis. MATERIAL AND METHODS: A comparative, random, open, prospective, longitudinal and multicenter study was made in 62 patients with an average age of 26.17 +/- 9.75 years (13-56 years) with diagnosis of perennial allergic rhinitis, who attended to external consultation of the different departments of allergy of the participant institutions. All patients were submitted to: complete clinical history, physical exploration, measurement of vital signs, nasal exploration, qualification of allergic symptoms and record of daily symptoms. Moreover, washout during a week and pharmacological treatment was given during two weeks. Symptoms referred by patient and findings of physical exploration during the different visits, as well as rhinoscopic findings, were assessed by a scale of five parameters of rhinitis. Tolerance grade of drugs was assessed based on frequency and severity of side effects. RESULTS: According to the basal clinical assessment symptoms qualification of patients of groups of epinastine and loratadine was of 9.12 +/- 2.78 and 7.90 +/- 2.7, respectively. Seven side effects appeared: three cases of somnolence, one of sickness and one of anxiety in patients of group of loratadine and one case of somnolence and one of dysmenorrhea in the subjects of group of epinestine. Although it did not have statistically significant difference, it is clinically important for patients. Frequency of side effects was higher in the loratadine group. CONCLUSION: Both drugs are efficient for the treatment of perennial allergic rhinitis.

[Risk management by reporting critical incidents. Vitamin K and ephedrine mix-up at a birthing unit]. / Risikostyring med rapportering af kritiske situationer. Forveksling af K-vitamin og ephedrin på en fødegang.

INTRODUCTION: Errors of medication are frequent causes of hazards to patients. It has been suggested that containers that look alike constitute a risk of such errors. In this article, we present an example of how reporting incidents of potential risks, can be applied in their clinical management. MATERIAL AND METHODS: As part of a medical technology assessment project on risk management in a delivery department, the staff were encouraged to report incidents that could create a potential risk to patients. The incidents were assessed by a project group as either a general problem to patient safety or a solitary incident. If considered a general problem, procedures should be changed and implemented in the department. RESULTS: Two incidents were reported, where ephedrine and adrenaline were found in a box supposed to contain vitamin K for new-born babies. These were considered a general problem by the project group, and the procedure for storing and managing ephedrine and adrenaline in the delivery department was changed to prevent new cases. DISCUSSION: Near misses occur more often than actual errors, and we argue that, as they are easier to discover, it is important to learn from them and thus prevent further incidents. A forum should be set up to exchange experiences of acknowledged risks, hazards, analytical results and preventive solutions.

Seudoefedrina. Valoración de su uso en cardiópatas con sinusitis / Pseudoephedrine. Evaluation of its use in patients with heart disease and sinusitis

La seudoefedrina es una amina simpaticomimética de mucho uso como descongestionante nasal, con efectos sistémicos secundarios entre ellos cardiovasculares; por ello, se realizó un estudio prospectivo en 25 pacientes con hipertensión arterial esencial sistémica controlada y/o cardiopatía isquémica que presentaban sinusitis aguda, con seudoefredina 60 mg c/12 hrs por 2 semanas contra placebo y grupo control, monitoreo por electrocardiografía ambulatoria, presión arterial ambulatoria, y revisión clínica. Los resultados demuestran que en pacientes controlados, el uso de seudoefedrina en las dosis recomendadas es útil y seguro. Se recomienda siempre la valoración por cardiólogo previa administración

[Comparative assessment of astemizole-pseudoephedrine and loratadine-pseudoephedrine in children with allergic rhinitis]. / Evaluación comparativa del astemizol-pseudoefedrina y loratadina-pseudoefedrina en niños con rinitis alérgica.

The purpose of the study was to evaluate the effectiveness and safety of astemizole-pseudoephedrine solution compared to loratadine-pseudoephedrine syrup in the treatment of allergic rhinitis. Fifty children (34 boys and 16 girls) ages between 2 and 7 years were enrolled and randomly assigned to each group. Patients were evaluated before treatment and on the third and seventh days of therapy. Children treated with astemizole-pseudoephedrine had better results with an average effectiveness of 84% compared to 64% for children treated with loratadine-pseudoephedrine. Differences were significant for eye symptoms by medical evaluation and for blocked nose, sneezing and itchy nose according to the patients diary. Both treatment groups started action within 30 minutes after drug intake. 4 hours later, 38% of the patients in the astemizole-pseudoephedrine group and 16% in the loratadine-pseudoephedrine groups had experienced improvement. One patient in the former and three in the latter showed adverse effects.

The acute and chronic effects of ephedrine/caffeine mixtures on energy expenditure and glucose metabolism in humans.

This paper describes a 24-week open follow-up trial with reduced obese patients all receiving an ephedrine/caffeine combination (20 mg/200 mg) three times a day. The study was a continuation of a previous 24-week double-blind placebo-controlled study where the ephedrine/caffeine mixture had shown superior weight-reducing properties when compared with either ephedrine alone (20 mg) or caffeine alone (200 mg) three times a day. The medication was stopped between weeks 24-26 in order to evaluate withdrawal symptoms. The follow-up period was from weeks 26 to 50. Of 127 patients included, 99 completed the follow-up treatment, which resulted in an additional weight loss of 1.1 kg (P = 0.02). Adverse drug reactions were all minor and temporary. We conclude that the ephedrine/caffeine combination is safe and effective in long-term treatment in improving and maintaining weight loss. The side-effects are minor and transient and no clinically relevant withdrawal symptoms have been observed.

Effect of ephedrine and theophylline on weight loss, resting energy expenditure and lipoprotein lipase activity in obese over-fed rats.

The effect of ephedrine (E) and theophylline (T), administered alone and in combination (E/T), on weight loss, resting energy expenditure and post-heparin lipoprotein lipase activity in plasma (PHLA) and in adipose tissue (ATLP) were investigated in obese over-fed rats, who had been diet restricted (-40% of normal caloric intake) for three weeks. E, T and E/T significantly increased weight loss in all experimental groups as compared to the controls. Weight loss was achieved not only by preventing the adaptive fall in resting energy expenditure associated with diet restriction, but by raising it above basal level. The effect of E/T mixture was no greater than that of E or T alone. E, T and E/T administration increased PHLA in plasma while hypocaloric diet alone did not influence the activity of the enzyme. ATLP in the epididymal fat pads decreased insignificantly in all experimental groups, as well as in the controls. Serum cholesterol levels were not influenced by hypocaloric diet and by drug administration, but serum triglycerides increased significantly in E, T and E/T treated groups. The elevation of PHLA after ephedrine and/or theophylline administration was mostly due to an increase in the hepatic lipase (HL) level. This enzyme contributes to the removal of the atherogenic intermediate density lipoproteins from blood serum. The increased HL activity in drug-treated, diet-restricted obese rats may therefore play a role in the prevention of atherosclerosis.

The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women.

Treatment with beta 2-agonists promotes fat loss and muscle growth in numerous species, but human studies are lacking. We studied the effect of a compound with beta 2-agonistic properties (ephedrine 20 mg/caffeine 200 mg [E + C]). Fourteen obese women were treated with a 4.2-MJ/d diet and either E + C or placebo (P) three times per day for 8 weeks in a double-blind study. Weight-loss was not different in the groups, but the E + C group lost 4.5 kg more body fat and 2.8 kg less fat-free mass (FFM). The decrease in 24-hour energy expenditure (EE) seen in the P group was 10% at day 1 and 13% at day 56, but was only 7% and 8% in the treated group (P = .044). The higher EE in the E +C group was entirely covered by fat oxidation. These findings provide evidence that promotion of fat loss and preservation of FFM during weight reduction may also be achieved pharmacologically in humans.

Effects of chronic administration of ephedrine during very-low-calorie diets on energy expenditure, protein metabolism and hormone levels in obese subjects.

1. We investigated the effects of the chronic administration of a sympathomimetic agent on energy expenditure, protein metabolism and levels of thyroid hormones and catecholamines in 10 obese subjects after a 6-week very-low-calorie-diet programme (1965 kJ, 60 g of protein, 45 g of carbohydrates). L-(-)-Ephedrine hydrochloride (50 mg three times a day by mouth) or placebo were administered during 2-week periods (weeks 2-5 of the VLCD programme) in a randomized, double-blind, cross-over design. Five subjects began with ephedrine and five with placebo. 2. The results were analysed separately in the two groups. No difference was found between them as regards weight loss during the very-low-calorie diet and drug treatments. Conversely, ephedrine therapy induced a significantly lower daily urinary excretion of nitrogen (and, consequently, a better nitrogen balance) with respect to placebo, independently of the drug sequence. Daily urinary levels of 3-methylhistidine during ephedrine and placebo treatments were similar. The fasting resting metabolic rate (oxygen consumption, ml STP/min) fell significantly during the very-low-calorie diet in both groups, but this effect was partially and significantly prevented by administration of ephedrine. Diet therapy significantly reduced 24 h urine levels of vanillylmandelic acid and homovanillic acid, which, however, increased to pretreatment values during ephedrine treatment. No significant effects were shown on 24 h urinary concentrations of adrenaline, noradrenaline and dopamine during the very-low-calorie diet and/or ephedrine treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Bioavailability assessment of a new liquid controlled-release pseudoephedrine product.

Development of a liquid controlled-release pseudoephedrine product is described. Two bioequivalence studies were conducted. In a single-dose study involving 20 subjects, the bioavailabilities of five controlled-release suspensions with a broad range of drug-release rates were compared with an immediate-release form of pseudoephedrine hydrochloride in a four-way crossover, incomplete block, sequence-randomized study. Serial blood sampling up to 36 hours after drug ingestion provided area-under-the-curve (AUC), maximum plasma concentration (Cmax), and time to peak (tmax). In the multiple-dose study, involving 18 subjects, the bioavailability of the optimal formulation determined from the single-dose study was compared with a reference pseudoephedrine hydrochloride syrup. Serial blood sampling up to 12 hours after drug ingestion was performed to determine AUC, Cmax, and tmax. The single-dose investigation showed that all formulations were bioequivalent except the product with the slowest release rate, which had lower AUC and Cmax values. The results of the multiple-dose study confirmed these findings with the reference syrup. The use of a series of drug formulations with a wide range of release rates permitted selection of an optimal product in addition to providing the information needed to ensure continuous production of bioequivalent products.