RESUMEN
BACKGROUND: Globally, >300 million patients have surgery annually, and ≤20% experience adverse postoperative events. We studied the impact of both cardiac and noncardiac adverse events on 1-year disability-free survival after noncardiac surgery. METHODS: We used the study cohort from the Evaluation of Nitrous oxide in Gas Mixture of Anesthesia (ENIGMA-II) trial, an international randomized trial of 6992 noncardiac surgical patients. All were ≥45 years of age and had moderate to high cardiac risk. The primary outcome was mortality within 1 postoperative year. We defined 4 separate types of postoperative adverse events. Major adverse cardiac events (MACEs) included myocardial infarction (MI), cardiac arrest, and myocardial revascularization with or without troponin elevation. MI was defined using the third Universal Definition and was blindly adjudicated. A second cohort consisted of patients with isolated troponin increases who did not meet the definition for MI. We also considered a cohort of patients who experienced major adverse postoperative events (MAPEs), including unplanned admission to intensive care, prolonged mechanical ventilation, wound infection, pulmonary embolism, and stroke. From this cohort, we identified a group without troponin elevation and another with troponin elevation that was not judged to be an MI. Multivariable Cox proportional hazard models for death at 1 year and assessments of proportionality of hazard functions were performed and expressed as an adjusted hazard ratio (aHR) and 95% confidence intervals (CIs). RESULTS: MACEs were observed in 469 patients, and another 754 patients had isolated troponin increases. MAPEs were observed in 631 patients. Compared with control patients, patients with a MACE were at increased risk of mortality (aHR, 3.36 [95% CI, 2.55-4.46]), similar to patients who suffered a MAPE without troponin elevation (n = 501) (aHR, 2.98 [95% CI, 2.26-3.92]). Patients who suffered a MAPE with troponin elevation but without MI had the highest risk of death (n = 116) (aHR, 4.29 [95% CI, 2.89-6.36]). These 4 types of adverse events similarly affected 1-year disability-free survival. CONCLUSIONS: MACEs and MAPEs occur at similar frequencies and affect survival to a similar degree. All 3 types of postoperative troponin elevation in this analysis were associated, to varying degrees, with increased risk of death and disability.
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Anestésicos por Inhalación/efectos adversos , Cardiopatías/epidemiología , Óxido Nitroso/efectos adversos , Procedimientos Quirúrgicos Operativos/efectos adversos , Administración por Inhalación , Anciano , Anestésicos por Inhalación/administración & dosificación , Biomarcadores/sangre , Evaluación de la Discapacidad , Femenino , Estado de Salud , Cardiopatías/diagnóstico , Cardiopatías/mortalidad , Cardiopatías/terapia , Humanos , Masculino , Persona de Mediana Edad , Óxido Nitroso/administración & dosificación , Medición de Riesgo , Factores de Riesgo , Procedimientos Quirúrgicos Operativos/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Troponina/sangre , Regulación hacia ArribaAsunto(s)
Analgésicos Opioides/efectos adversos , Lactancia Materna , Contraindicaciones de los Medicamentos , Tramadol/efectos adversos , Analgésicos Opioides/metabolismo , Analgésicos Opioides/farmacocinética , Humanos , Recién Nacido , Seguridad del Paciente , Guías de Práctica Clínica como Asunto , Tramadol/metabolismo , Tramadol/farmacocinéticaAsunto(s)
Infarto del Miocardio/sangre , Infarto del Miocardio/mortalidad , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/mortalidad , Troponina/sangre , Biomarcadores/sangre , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Complicaciones Posoperatorias/diagnóstico , Tasa de Supervivencia/tendenciasRESUMEN
The effect of pethidine as patient-controlled epidural analgesia (PCEA) on specific biochemical components in breast milk in relation to the timing of secretory activation is not well investigated. The aim of this study was to compare biochemical timing of secretory activation between women who had a vaginal (V) or Caesarean birth with pethidine-PCEA (CBP). Several milk samples were collected daily from 36 mothers (17 V, 19 CBP) for the first 265 h post-partum. Protein and lactose concentrations and Na+ and K+ ion levels were measured. Samples were assigned to three time periods: 0-72, >72-165 and >165-265 h post-partum for statistical analyses. Data were analyzed using linear mixed effect models. In the first 72 h post-partum, the mean difference in lactose concentration was 5 gL-1 higher in group V (P < 0.05). From >72-165 h post-partum, protein and Na+ concentrations were lower in group V (P = 0.05, P = 0.02), and K+ levels were higher in group V (P < 0.001). From >165-265 h post-partum, there were no significant differences between the groups. Biochemically, secretory activation had occurred by 72 h post-partum in both groups. There were greater variations in measured biochemical components observed within group CBP initially. However, by 165 h post-partum, there were no differences in the biochemical components between the groups. This suggests that effects of pethidine-PCEA are diminished by 72 h post-partum and undetected by 165 h.
Asunto(s)
Analgesia Controlada por el Paciente/efectos adversos , Meperidina/efectos adversos , Leche Humana/química , Adulto , Cesárea , Grasas de la Dieta/análisis , Femenino , Humanos , Lactosa/análisis , Proteínas de la Leche/análisis , Periodo Posparto , Potasio/análisis , Sodio/análisisAsunto(s)
Anestesiología , Internacionalidad , Obstetricia , Femenino , Humanos , Publicaciones Periódicas como Asunto , EmbarazoRESUMEN
ABSTRACT OBJECTIVE: Several devices can aid nasotracheal intubation when managing difficult airways. The McGrath MAC and Airtraq NT were compared with a Macintosh laryngoscope when studying the performance of anaesthetists with different levels of experience, in a manikin model of easy or difficult airway scenarios. METHODS: Sixty-three anaesthetists were recruited into a randomised trial in which each performed nasotracheal intubation with all laryngoscopes, in both scenarios. The main endpoint was intubation time. Additional endpoints included laryngoscopic view, intubation success, number of optimisation manoeuvres, audible dental clicks and the force applied to the upper airway. RESULTS: Intubation time was significantly shorter using the McGrath MAC in both scenarios and using the Airtraq in the difficult scenario, when compared with the Macintosh laryngoscope. Both devices gave more Cormack and Lehane grade 1 or 2 views than the Macintosh in the difficult scenario (p < 0.001). The McGrath MAC had the best first-attempt success rate (98.4% vs. 96.8% and 95.8%, p < 0.001 for the Airtraq NT and Macintosh laryngoscopes respectively). The number of optimisation manoeuvres, audible dental clicks and subjective assessment of the degree of force applied were significantly lower for indirect laryngoscopes versus the Macintosh laryngoscope (p < 0.001). CONCLUSION: In a manikin, the Airtraq and the McGrath laryngoscopes appeared superior to the Macintosh laryngoscope when dealing with simulated airway scenarios. Both devices were associated with better views, intubation times and rates of success, especially in a simulated "difficult airway". Overall satisfaction was highest with the McGrath laryngoscope. Similar clinical studies are needed.
RESUMO OBJETIVO: Vários dispositivos podem ajudar a intubação nasotraqueal no manejo de via aérea difícil. Os laringoscópios McGrath MAC e Airtraq NT foram comparados com um laringoscópio Macintosh em estudo do desempenho de anestesistas com diferentes níveis de experiência, em manequim com cenário de via aérea fácil ou difícil. MÉTODOS: Foram recrutados 63 anestesistas para um estudo randômico, no qual cada um fez intubação nasotraqueal com todos os laringoscópios, em ambos os cenários. O desfecho primário foi o tempo de intubação. Desfechos adicionais incluíram vista laringoscópica, sucesso na intubação, número de manobras de aprimoramento, cliques dentais audíveis e força aplicada nas vias aéreas superiores. RESULTADOS: O tempo de intubação foi significativamente menor com o uso do laringoscópio McGrath MAC em ambos os cenários e com o uso do Airtraq no cenário difícil, em comparação com o laringoscópio Macintosh. Ambos os dispositivos obtiveram mais grau 1 ou 2 de Cormack e Lehane para visualização do que o Macintosh em cenário difícil (p < 0,001). O McGrath MAC teve a melhor taxa de sucesso na primeira tentativa (98,4% vs. 96,8% e 95,8%, p < 0,001, para os laringoscópios Airtraq NT e Macintosh, respectivamente). O número de manobras de aprimoramento, os cliques dentais audíveis e a avaliação subjetiva do grau de força aplicada foram significativamente menores para os laringoscópios indiretos versus o laringoscópio Macintosh (p < 0,001). CONCLUSÃO: Em um manequim, os laringoscópios Airtraq e McGrath pareceram superiores ao laringoscópio Macintosh para lidar com cenários das vias aéreas simuladas. Ambos os dispositivos foram associados a melhores visibilidades, tempos de intubação e taxas de sucesso, especialmente em simulação de "via aérea difícil". A satisfação geral foi maior com o laringoscópio McGrath. Estudos clínicos similares são necessários.
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Laringoscopios , Intubación Intratraqueal/instrumentación , Laringoscopía/instrumentación , Maniquíes , Factores de Tiempo , Estudios Cruzados , Diseño de Equipo , Intubación Intratraqueal/métodosRESUMEN
OBJECTIVE: Several devices can aid nasotracheal intubation when managing difficult airways. The McGrath MAC and Airtraq NT were compared with a Macintosh laryngoscope when studying the performance of anaesthetists with different levels of experience, in a manikin model of easy or difficult airway scenarios. METHODS: Sixty-three anaesthetists were recruited into a randomised trial in which each performed nasotracheal intubation with all laryngoscopes, in both scenarios. The main endpoint was intubation time. Additional endpoints included laryngoscopic view, intubation success, number of optimisation manoeuvres, audible dental clicks and the force applied to the upper airway. RESULTS: Intubation time was significantly shorter using the McGrath MAC in both scenarios and using the Airtraq in the difficult scenario, when compared with the Macintosh laryngoscope. Both devices gave more Cormack and Lehane grade 1 or 2 views than the Macintosh in the difficult scenario (p<0.001). The McGrath MAC had the best first-attempt success rate (98.4% vs. 96.8% and 95.8%, p<0.001 for the Airtraq NT and Macintosh laryngoscopes respectively). The number of optimisation manoeuvres, audible dental clicks and subjective assessment of the degree of force applied were significantly lower for indirect laryngoscopes versus the Macintosh laryngoscope (p<0.001). CONCLUSION: In a manikin, the Airtraq and the McGrath laryngoscopes appeared superior to the Macintosh laryngoscope when dealing with simulated airway scenarios. Both devices were associated with better views, intubation times and rates of success, especially in a simulated "difficult airway". Overall satisfaction was highest with the McGrath laryngoscope. Similar clinical studies are needed.
Asunto(s)
Intubación Intratraqueal/instrumentación , Laringoscopios , Laringoscopía/instrumentación , Maniquíes , Adulto , Estudios Cruzados , Diseño de Equipo , Femenino , Humanos , Intubación Intratraqueal/métodos , Masculino , Factores de TiempoRESUMEN
OBJECTIVE: Several devices can aid nasotracheal intubation when managing difficult airways. The McGrath MAC and Airtraq NT were compared with a Macintosh laryngoscope when studying the performance of anaesthetists with different levels of experience, in a manikin model of easy or difficult airway scenarios. METHODS: Sixty-three anaesthetists were recruited into a randomised trial in which each performed nasotracheal intubation with all laryngoscopes, in both scenarios. The main endpoint was intubation time. Additional endpoints included laryngoscopic view, intubation success, number of optimisation manoeuvres, audible dental clicks and the force applied to the upper airway. RESULTS: Intubation time was significantly shorter using the McGrath MAC in both scenarios and using the Airtraq in the difficult scenario, when compared with the Macintosh laryngoscope. Both devices gave more Cormack and Lehane grade 1 or 2 views than the Macintosh in the difficult scenario (p<0.001). The McGrath MAC had the best first-attempt success rate (98.4% vs. 96.8% and 95.8%, p<0.001 for the Airtraq NT and Macintosh laryngoscopes respectively). The number of optimisation manoeuvres, audible dental clicks and subjective assessment of the degree of force applied were significantly lower for indirect laryngoscopes versus the Macintosh laryngoscope (p<0.001). CONCLUSION: In a manikin, the Airtraq and the McGrath laryngoscopes appeared superior to the Macintosh laryngoscope when dealing with simulated airway scenarios. Both devices were associated with better views, intubation times and rates of success, especially in a simulated "difficult airway". Overall satisfaction was highest with the McGrath laryngoscope. Similar clinical studies are needed.
RESUMEN
BACKGROUND: The Evaluation of Nitrous oxide in the Gas Mixture for Anesthesia II trial randomly assigned 7,112 noncardiac surgery patients to a nitrous oxide or nitrous oxide-free anesthetic; severe postoperative nausea and vomiting (PONV) was a prespecified secondary end point. Thus, the authors evaluated the association between nitrous oxide, severe PONV, and effectiveness of PONV prophylaxis in this setting. METHODS: Univariate and multivariate analyses of patient, surgical, and other perioperative characteristics were used to identify the risk factors for severe PONV and to measure the impact of severe PONV on patient outcomes. RESULTS: Avoiding nitrous oxide reduced the risk of severe PONV (11 vs. 15%; risk ratio [RR], 0.74 [95% CI, 0.63 to 0.84]; P < 0.001), with a stronger effect in Asian patients (RR, 0.55 [95% CI, 0.43 to 0.69]; interaction P = 0.004) but lower effect in those who received PONV prophylaxis (RR, 0.89 [95% CI, 0.76 to 1.05]; P = 0.18). Gastrointestinal surgery was associated with an increased risk of severe PONV when compared with most other types of surgery (P < 0.001). Patients with severe PONV had lower quality of recovery scores (10.4 [95% CI, 10.2 to 10.7] vs. 13.1 [95% CI, 13.0 to 13.2], P < 0.0005); severe PONV was associated with postoperative fever (15 vs. 20%, P = 0.001). Patients with severe PONV had a longer hospital stay (adjusted hazard ratio, 1.14 [95% CI, 1.05 to 1.23], P = 0.002). CONCLUSIONS: The increased risk of PONV with nitrous oxide is near eliminated by antiemetic prophylaxis. Severe PONV, which is seen in more than 10% of patients, is associated with postoperative fever, poor quality of recovery, and prolonged hospitalization.
Asunto(s)
Anestesia por Inhalación/efectos adversos , Anestésicos por Inhalación/efectos adversos , Óxido Nitroso/efectos adversos , Náusea y Vómito Posoperatorios/epidemiología , Anciano , Periodo de Recuperación de la Anestesia , Antieméticos/uso terapéutico , Pueblo Asiatico , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Determinación de Punto Final , Femenino , Fiebre/epidemiología , Fiebre/etiología , Humanos , Estimación de Kaplan-Meier , Longevidad , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Náusea y Vómito Posoperatorios/prevención & control , Factores de Riesgo , Resultado del Tratamiento , Población BlancaRESUMEN
BACKGROUND: The Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia (ENIGMA)-II trial randomly assigned 7,112 noncardiac surgery patients at risk of perioperative cardiovascular events to 70% N2O or 70% N2 groups. The aim of this follow-up study was to determine the effect of nitrous oxide on a composite primary outcome of death and major cardiovascular events at 1 yr after surgery. METHODS: One-year follow-up was conducted via a medical record review and telephone interview. Disability was defined as a Katz index of independence in activities of daily living score less than 8. Adjusted odds ratios and hazard ratios were calculated as appropriate for primary and secondary outcomes. RESULTS: Among 5,844 patients evaluated at 1 yr, 435 (7.4%) had died, 206 (3.5%) had disability, 514 (8.8%) had a fatal or nonfatal myocardial infarction, and 111 (1.9%) had a fatal or nonfatal stroke during the 1-yr follow-up period. Exposure to nitrous oxide did not increase the risk of the primary outcome (odds ratio, 1.08; 95% CI, 0.94 to 1.25; P = 0.27), disability or death (odds ratio, 1.07; 95% CI, 0.90 to 1.27; P = 0.44), death (hazard ratio, 1.17; 95% CI, 0.97 to 1.43; P = 0.10), myocardial infarction (odds ratio, 0.97; 95% CI, 0.81 to 1.17; P = 0.78), or stroke (odds ratio, 1.08; 95% CI, 0.74 to 1.58; P = 0.70). CONCLUSION: These results support the long-term safety of nitrous oxide administration in noncardiac surgical patients with known or suspected cardiovascular disease.
Asunto(s)
Anestésicos por Inhalación/efectos adversos , Enfermedades Cardiovasculares/epidemiología , Óxido Nitroso/efectos adversos , Complicaciones Posoperatorias/epidemiología , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Medición de RiesgoRESUMEN
This guideline is an evidence based, practical clinical approach to the management of Hypertensive Disorders of Pregnancy. Since the previous SOMANZ guideline published in 2008, there has been significant international progress towards harmonisation of definitions in relation to both the diagnosis and management of preeclampsia and gestational hypertension. This reflects increasing knowledge of the pathophysiology of these conditions, as well as their clinical manifestations. In addition, the guideline includes the management of chronic hypertension in pregnancy, an approach to screening, advice regarding prevention of hypertensive disorders of pregnancy, and discussion of recurrence risks and long term risk to maternal health. The literature reviewed included the previous SOMANZ Hypertensive Disorders of Pregnancy guideline from 2008 and its reference list, plus all other published National and International Guidelines on this subject. Medline, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Registry of Controlled Trials (CCRCT), National Institute for Health and Care Excellence (NICE) Evidence Search, and Database of Abstracts and Reviews of Effects (DARE) were searched for literature published between January 2007 and March, 2014.
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Antihipertensivos/uso terapéutico , Hipertensión Inducida en el Embarazo/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Preeclampsia/terapia , Resultado del Embarazo , Adulto , Determinación de la Presión Sanguínea/métodos , Progresión de la Enfermedad , Medicina Basada en la Evidencia , Femenino , Edad Gestacional , Humanos , Hipertensión Inducida en el Embarazo/diagnóstico , Monitoreo Fisiológico/métodos , Preeclampsia/diagnóstico , Embarazo , Medición de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoAsunto(s)
Antihipertensivos/uso terapéutico , Hipertensión Inducida en el Embarazo/diagnóstico , Hipertensión Inducida en el Embarazo/terapia , Espera Vigilante , Australia , Parto Obstétrico , Femenino , Humanos , Hipertensión Inducida en el Embarazo/clasificación , Hipertensión Inducida en el Embarazo/prevención & control , Nueva Zelanda , Atención Preconceptiva , EmbarazoRESUMEN
BACKGROUND: Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. METHODS: We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. FINDINGS: Of 10,102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·831·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (p<0·0001). INTERPRETATION: Our findings support the safety profile of nitrous oxide use in major non-cardiac surgery. Nitrous oxide did not increase the risk of death and cardiovascular complications or surgical-site infection, the emetogenic effect of nitrous oxide can be controlled with antiemetic prophylaxis, and a desired effect of reduced volatile agent use was shown. FUNDING: Australian National Health and Medical Research Council; Australian and New Zealand College of Anaesthetists; Heart and Stroke Foundation of Quebec, Heart and Stroke Foundation of Ontario, Canada; General Research Fund of the Research Grant Council, Hong Kong Special Administrative Region, China.
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Anestesia General/efectos adversos , Anestésicos por Inhalación/efectos adversos , Enfermedad de la Arteria Coronaria/complicaciones , Óxido Nitroso/efectos adversos , Anciano , Anestesia General/métodos , Anestésicos Combinados/efectos adversos , Enfermedades Cardiovasculares/inducido químicamente , Enfermedades Cardiovasculares/epidemiología , Enfermedad de la Arteria Coronaria/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Náusea y Vómito Posoperatorios/inducido químicamente , Náusea y Vómito Posoperatorios/epidemiología , Estudios Prospectivos , Medición de Riesgo/métodos , Método Simple Ciego , Infección de la Herida Quirúrgica/epidemiologíaRESUMEN
It is widely recognized that childbirth may be the most painful experience in a woman's lifetime and that women have a right to relief. There are many options, but the efficacy of only a few is supported by robust evidence. Many influences determine which method of pain relief is chosen, including social and cultural factors, availability, cost and personal preference. Due to human diversity and the differing perspectives of consumers, obstetric care providers and health administrators, there is no such thing as 'an ideal approach'. In resource-rich societies, major advances in parturient safety and outcome flow from technique development and better monitoring. Greater awareness of the negative impact of untreated pain and of the relevance of genetic, cultural and social factors motivates research into better predictive models, novel therapies and optimization of existing methods.
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Analgesia Obstétrica , Dolor de Parto , Femenino , Humanos , EmbarazoRESUMEN
Nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin, which are available as "over-the counter" medications in most countries, are widely used by both pregnant and lactating women. They are popular non-opioid analgesics for the treatment of pain after vaginal and operative delivery. In addition, NSAIDs are used for tocolysis in premature labor, and low-dose aspirin has a role in the prevention of preeclampsia and recurrent miscarriage in antiphospholipid syndrome. NSAIDs and aspirin may affect fertility and increase the risk of early pregnancy loss. In the second trimester their use is considered reasonably safe, but has been associated with fetal cryptorchism. In the third trimester, NSAIDs and aspirin are usually avoided because of significant fetal risks such as renal injury, oligohydramnios, constriction of the ductus arteriosus (with potential for persistent pulmonary hypertension in the newborn), necrotizing enterocolitis, and intracranial hemorrhage. Maternal administration or ingestion of most NSAIDs results in low infant exposure via breastmilk, such that both cyclooxygenase-1 and cyclooxygenase-2 inhibitors are generally considered safe, and preferable to aspirin, when breastfeeding.
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Antiinflamatorios no Esteroideos/efectos adversos , Lactancia/fisiología , Aborto Habitual/etiología , Aborto Habitual/prevención & control , Adulto , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/farmacocinética , Antiinflamatorios no Esteroideos/uso terapéutico , Síndrome Antifosfolípido/complicaciones , Aspirina/efectos adversos , Aspirina/uso terapéutico , Lactancia Materna , Anomalías Congénitas/epidemiología , Femenino , Fertilización In Vitro , Humanos , Lactante , Recién Nacido , Leche Humana/metabolismo , Manejo del Dolor , Dolor Postoperatorio/tratamiento farmacológico , Periodo Posparto , Preeclampsia/prevención & control , Embarazo , Primer Trimestre del Embarazo , Segundo Trimestre del Embarazo , Tercer Trimestre del EmbarazoRESUMEN
BACKGROUND: The objective of this study was to prepare a novel fentanyl wafer formulation by a freeze-drying method, and to evaluate its in vitro and in vivo release characteristics, including its bioavailability via the sublingual route. METHODS: The wafer formulation was prepared by freeze-drying an aqueous dispersion of fentanyl containing sodium carboxymethylcellulose and amylogum as matrix formers. Uniformity of weight, friability, and dissolution testing of the fentanyl wafer was achieved using standard methods, and the residual moisture content was measured. The fentanyl wafer was also examined using scanning electron microscopy and x-ray diffraction. The absolute bioavailability of the fentanyl wafer was evaluated in 11 opioid-naïve adult female patients using a randomized crossover design. RESULTS: In vitro release showed that almost 90% of the fentanyl dissolved in one minute. In vivo, the first detectable plasma fentanyl concentration was observed after 3.5 minutes and the peak plasma concentration between 61.5 and 67 minutes. The median absolute bioavailability was 53.0%. CONCLUSION: These results indicate that this wafer has potential as an alternative sublingual fentanyl formulation.
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Analgésicos Opioides/farmacocinética , Excipientes/química , Fentanilo/farmacocinética , Administración Sublingual , Adulto , Anciano , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/química , Disponibilidad Biológica , Carboximetilcelulosa de Sodio/química , Estudios Cruzados , Femenino , Fentanilo/administración & dosificación , Fentanilo/química , Liofilización , Humanos , Microscopía Electrónica de Rastreo , Persona de Mediana Edad , Proyectos Piloto , Solubilidad , Difracción de Rayos X , Adulto JovenRESUMEN
BACKGROUND: In this post hoc subanalysis of the Perioperative Ischemic Evaluation (POISE) trial, we sought to determine whether nitrous oxide was associated with the primary composite outcome of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal cardiac arrest within 30 days of randomization. METHODS: The POISE trial of perioperative ß-blockade was undertaken in 8351 patients. Nitrous oxide anesthesia was defined as the coadministration of nitrous oxide in patients receiving general anesthesia, with or without additional neuraxial blockade or peripheral nerve blockade. Logistic regression, with inverse probability weighting using estimated propensity scores, was used to determine the association of nitrous oxide with the primary outcome, MI, stroke, death, and clinically significant hypotension. RESULTS: Nitrous oxide was administered to 1489 (29%) of the 5133 patients included in this analysis. Nitrous oxide had no significant effect on the risk of the primary outcome (112 [7.5%] vs 248 [6.9%]; odds ratio [OR], 1.08; 95% confidence interval [CI], 0.82-1.44; 99% CI, 0.75-1.57; P = 0.58), MI (89 [6.0] vs 204 [5.6]; OR, 0.99; 95% CI, 0.75-1.31; 99% CI, 0.69-1.42; P = 0.94), stroke (6 [0.4%] vs 28 [0.8%]; OR, 0.85; 95% CI, 0.26-2.82; 99% CI, 0.17-4.11; P = 0.79), death (40 [2.7%] vs 100 [2.8%]; OR, 1.04; 95% CI, 0.6-1.81; 99% CI, 0.51-2.15; P = 0.88) or clinically significant hypotension (219 [14.7%] vs 544 [15.0%]; OR, 0.92; 95% CI, 0.74-1.15; 99% CI, 0.70-1.23; P = 0.48). CONCLUSIONS: In this post hoc subanalysis, nitrous oxide was not associated with an increased risk of adverse outcomes in the POISE trial patients. This analysis was limited by the observational nature of the data and the lack of information on the concentration and duration of nitrous oxide administration. Further randomized controlled trial evidence is required.
Asunto(s)
Anestésicos por Inhalación/efectos adversos , Complicaciones Intraoperatorias/epidemiología , Complicaciones Intraoperatorias/mortalidad , Óxido Nitroso/efectos adversos , Periodo Perioperatorio/mortalidad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/mortalidad , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Anestesia por Inhalación/efectos adversos , Intervalos de Confianza , Interpretación Estadística de Datos , Método Doble Ciego , Utilización de Medicamentos , Femenino , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Modelos Logísticos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Oportunidad Relativa , Medicación Preanestésica , Puntaje de Propensión , Factores Sexuales , Resultado del TratamientoRESUMEN
BACKGROUND: Infant sucking problems are frequently implicated in early weaning during breastfeeding, yet our understanding of early sucking dynamics is limited. OBJECTIVE: This study aimed to describe infant sucking patterns during breastfeeding at secretory activation and determine whether they changed by the time of established lactation. METHODS: Sucking patterns and milk intake of 15 breastfeeding infants were assessed on day 3.2 ± 0.8 and later at follow-up, 16.0 (11.3-22.8) days postpartum. Nipple diameters, tongue movement, nipple position, and suck rate during nutritive sucking (NS) and non-nutritive sucking (NNS) were measured from ultrasound scans of the intra-oral cavity during breastfeeding. Milk intake and LATCH scores were also recorded. RESULTS: As the tongue lowered during a suck cycle, the nipple increased in size (P < .001), milk flowed into the intra-oral space and the nipple moved closer to the hard-soft palate junction (P < .001). During NS, nipple diameters and the mid-tongue movement were greater than during NNS (P < .001). As the infant aged, the mid-tongue lowered further (P = .002), suck rates became faster (P < .001) and milk intake increased (P = .004), however, no differences were seen for LATCH scores (P = .34). CONCLUSION: Differences in tongue movement between NS and NNS suggest that there is an altered sucking action when milk flow is absent. Similar sucking patterns at day 3 and during established lactation imply that infants have a mature sucking pattern in the early postpartum period.
Asunto(s)
Lactancia Materna , Boca/diagnóstico por imagen , Conducta en la Lactancia , Ingestión de Alimentos , Ingestión de Energía , Humanos , Recién Nacido , Pezones/diagnóstico por imagen , Factores de Tiempo , Lengua , UltrasonografíaRESUMEN
BACKGROUND: The impact of cesarean section (CS) birth and pethidine for post-CS epidural analgesia on early breastfeeding behavior is unclear. This study aimed to measure infant sucking and breastfeeding behavior in infants of mothers who delivered by CS (CS group) and used pethidine patient-controlled epidural analgesia (PCEA) after CS with that of infants who were delivered by vaginal birth (V group), during secretory activation and again after the establishment of lactation. SUBJECTS AND METHODS: Sucking dynamics and milk intake of breastfeeding infants were assessed on approximately 3 and 20 (follow-up) days postpartum (CS group, n=19; V group, n=15). Nipple diameters, tongue movement, and nipple position during sucking were measured from ultrasound scans of the intra-oral cavity during breastfeeding. Time of the first breastfeed and day of breast fullness were recorded, and infant neurobehavior was assessed. RESULTS: CS infants displayed more anterior tongue movement on Day 3 than at follow-up compared with the V group, which showed a similar amount of movement at each assessment (p for interaction<0.001). Compared with the V group, the CS group showed faster suck rates, especially on Day 3 (p<0.001), later times to first breastfeed (p=0.01) and breast fullness (p=0.03), and lower neurobehavioral scores (p=0.047). Breastfeeding duration and milk intake were similar between groups. CONCLUSIONS: Although the observed effect of CS birth followed by pethidine PCEA after CS during the period of secretory activation was small, our results indicate that successful initiation of lactation may require additional breastfeeding support and monitoring at Day 3 postpartum for mothers who undergo CS.