RESUMEN
BACKGROUND: Pain is a devastating sensation and has to be treated immediately. Therefore, we developed a training program to improve the knowledge of medical students in the field of pain medicine. In the present study, the applicability and efficacy of this training program was tested. METHODS: Half of the students attended first a training with simulated patients (SP) followed by bedside teaching (Group 1). Group 2 performed the training programs in reverse order. The evaluation based on standardized questionnaires completed by students (self-assessment) and all students took part in two practical examinations after the learning interventions. RESULTS: This study included 35 students. The quality of the simulation was evaluated by the students with average grade 1.1 (1 = very good, 6 = very bad). The practical work on the ward with patients was rated with grade 1.4 of 6, the whole course with 1.1. Students of Group A were significantly better in the final examination (grade 1.7 vs. grade 2.2, p < 0.05). To rate the improvement of skills (self-assessment) we used a Likert Scale (1 = very certain, 5 = very uncertain). The following skills were similar in both groups and significantly better after the course: taking responsibility, expert knowledge, empathy, relationship building and communication. CONCLUSIONS: Training with simulated patients in combination with small-group teaching at the bedside with real patients achieves a dramatic increase in student competence. Students prefer learning from the simulation before bedside teaching and propose to include simulation into the curricular teaching of pain medicine.
Asunto(s)
Competencia Clínica , Educación Médica/métodos , Evaluación Educacional , Manejo del Dolor , Adulto , Comunicación , Curriculum , Empatía , Femenino , Alemania , Humanos , Masculino , Estudiantes de Medicina/psicologíaRESUMEN
Palliative care is becoming increasingly important in intensive care units. The main goal of palliative treatment is to improve quality of life in patients with critical and life-threatening conditions when curative therapies can no longer be achieved. Treatment is not limited to end-of-life care, but also includes relief of distressing symptoms such as pain, nausea, vomiting, dyspnea, delirium or anxiety, as well as communication with patients and their families. Defining patient-centred goals of care together with patients, relatives and intensive care staff supports shared decision-making. Aspects of palliative care can be integrated in the ICU in different ways. The "integrative model" presumes that all patients with critical illness may benefit from palliative care principles and interventions practiced by the ICU team. The "consultative model" involves palliative care consultants in the care of ICU patients with palliative care need that may be identified using trigger criteria. This article gives an overview on different aspects of palliative care in intensive care units and provides practical advice for the implementation of palliative care in the ICU.
Asunto(s)
Unidades de Cuidados Intensivos , Cuidados Paliativos , Cuidado Terminal , Cuidados Críticos , Humanos , Calidad de VidaRESUMEN
BACKGROUND: The aim of our study was the identification of genetic variants associated with postoperative complications after cardiac surgery. METHODS: We conducted a prospective, double-blind, multicenter, randomized trial (RIPHeart). We performed a genome-wide association study (GWAS) in 1170 patients of both genders (871 males, 299 females) from the RIPHeart-Study cohort. Patients undergoing non-emergent cardiac surgery were included. Primary endpoint comprises a binary composite complication rate covering atrial fibrillation, delirium, non-fatal myocardial infarction, acute renal failure and/or any new stroke until hospital discharge with a maximum of fourteen days after surgery. RESULTS: A total of 547,644 genotyped markers were available for analysis. Following quality control and adjustment for clinical covariate, one SNP reached genome-wide significance (PHLPP2, rs78064607, p = 3.77 × 10- 8) and 139 (adjusted for all other outcomes) SNPs showed promising association with p < 1 × 10- 5 from the GWAS. CONCLUSIONS: We identified several potential loci, in particular PHLPP2, BBS9, RyR2, DUSP4 and HSPA8, associated with new-onset of atrial fibrillation, delirium, myocardial infarction, acute kidney injury and stroke after cardiac surgery. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov NCT01067703, prospectively registered on 11 Feb 2010.
Asunto(s)
Lesión Renal Aguda/genética , Fibrilación Atrial/genética , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Delirio/genética , Infarto del Miocardio/genética , Polimorfismo de Nucleótido Simple , Accidente Cerebrovascular/genética , Lesión Renal Aguda/diagnóstico , Anciano , Fibrilación Atrial/diagnóstico , Proteínas del Citoesqueleto/genética , Delirio/diagnóstico , Fosfatasas de Especificidad Dual/genética , Femenino , Predisposición Genética a la Enfermedad , Estudio de Asociación del Genoma Completo , Proteínas del Choque Térmico HSC70/genética , Humanos , Masculino , Persona de Mediana Edad , Fosfatasas de la Proteína Quinasa Activada por Mitógenos/genética , Estudios Multicéntricos como Asunto , Infarto del Miocardio/diagnóstico , Fosfoproteínas Fosfatasas/genética , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Canal Liberador de Calcio Receptor de Rianodina/genética , Accidente Cerebrovascular/diagnóstico , Resultado del TratamientoRESUMEN
BACKGROUND: Postoperative nausea and vomiting (PONV) is an extremely distressing side effect for patients. Despite PONV prophylaxis guided by well established scoring systems, the incidence of PONV is still high. OBJECTIVE: The aim of the current study was to investigate the predictive value of anxiety sensitivity as an additional independent risk factor for PONV in patients with an increased risk of PONV. DESIGN: A noninterventional, observational study. SETTING: A tertiary care university hospital. PATIENTS: Patients with an increased risk of PONV (i.e. female, nonsmoking) undergoing elective surgery (general, gynaecological, urological, musculoskeletal or neurosurgical) under general anaesthesia. MAIN OUTCOME MEASURES: The number of patients with anxiety sensitivity assessed pre-operatively with the Anxiety Sensitivity Index-3 questionnaire, the number of patients experiencing PONV, predictive value of anxiety sensitivity compared with other established risk factors for PONV. RESULTS: Some 41.5% of the patients experienced PONV within the first 24âh after surgery. In these patients increased anxiety sensitivity (Anxiety Sensitivity Index-3 score higher than seven points) was associated with a five-fold increase in the odds ratio (OR) for PONV. From the regression model, the risk of PONV was increased by lack of PONV prophylaxis (OR, 3.68), the postoperative administration of opioids (OR, 3.60) and patient age (OR, 1.03), but laparoscopic surgery did not increase the risk. CONCLUSION: In addition to the well established risk factors, anxiety sensitivity can help to predict the risk of PONV. It seems justifiable to add psychological factors such as anxiety sensitivity to PONV risk-scores. PONV prophylaxis should be considered when anxiety sensitivity is high. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01875120.
Asunto(s)
Anestesia General/efectos adversos , Ansiedad/psicología , Procedimientos Quirúrgicos Electivos/efectos adversos , Náusea y Vómito Posoperatorios/diagnóstico , Adulto , Factores de Edad , Anciano , Antieméticos , Ansiedad/diagnóstico , Estudios de Factibilidad , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Náusea y Vómito Posoperatorios/epidemiología , Náusea y Vómito Posoperatorios/etiología , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Pruebas Psicológicas , Medición de Riesgo/métodos , Factores de RiesgoRESUMEN
BACKGROUND: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains. METHODS: We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90. RESULTS: A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-RIPC group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis. No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium. No RIPC-related adverse events were observed. CONCLUSIONS: Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery. (Funded by the German Research Foundation; RIPHeart ClinicalTrials.gov number, NCT01067703.).
Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Precondicionamiento Isquémico/métodos , Complicaciones Posoperatorias/prevención & control , Anciano , Anestesia Intravenosa , Puente Cardiopulmonar , Método Doble Ciego , Procedimientos Quirúrgicos Electivos , Femenino , Humanos , Isquemia , Estimación de Kaplan-Meier , Tiempo de Internación , Masculino , Persona de Mediana Edad , Propofol , Estudios Prospectivos , Insuficiencia del Tratamiento , Troponina/sangre , Extremidad Superior/irrigación sanguíneaRESUMEN
BACKGROUND: Ongoing pain after surgery is a major problem and influences recovery and the quality of life of the patient. Associations between anxiety and their impact on postoperative pain after herniated disc surgery have been reported, but the results are inconsistent. The aim of the present longitudinal study was to evaluate the predictive value of preoperative anxiety for postoperative ongoing pain and prolonged analgesic intake after herniated disc surgery. METHODS: 106 patients with lumbar disc herniation were evaluated in the study. Anxiety was measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7) before surgery. Pain intensity was assessed on a numeric rating scale (NRS) at baseline, 6-weeks and 6-months after surgery. Regression analysis was performed to identify independent predictors of pain and regular utilization of analgesics up to 6 months after surgery while controlling for confounding variables. RESULTS: 42.5% of the patients were rated as anxiety cases (sum scores GAD-7 > 5), mean scores of anxiety showed mild to moderate symptom severity, and 43% suffered from chronic pain before surgery. Six months after surgery, 55.6% of the patients indicated pain levels of 4/10 (NRS) or higher and about 40% still took pain medication on a regular basis, regardless of their preoperative classification as anxiety-case (37.7% and 41.5%). The preoperative pain level was statistically significant for ongoing postsurgical pain in all four analyses (p < 0.001). With binary logistic regression analyses, preoperative pain intensity, but neither demographic factors nor preoperative anxiety, was identified as predictor for postoperative pain and need for analgesic medication up to 6 months after lumbar disc surgery. CONCLUSION: We found no evidence for the presence of anxiety before disc surgery being a prognostic factor for ongoing pain and regular postoperative intake of analgesics. Only preoperative pain intensity was predictive for increased pain and continued need for analgesic medication up to 6 months after lumbar disc surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT01488617 . Registered 6 December 2011.
Asunto(s)
Analgésicos/uso terapéutico , Ansiedad/psicología , Dolor Crónico/psicología , Desplazamiento del Disco Intervertebral/psicología , Dolor Postoperatorio/psicología , Adulto , Ansiedad/etiología , Dolor Crónico/tratamiento farmacológico , Evaluación de la Discapacidad , Femenino , Humanos , Desplazamiento del Disco Intervertebral/cirugía , Estudios Longitudinales , Vértebras Lumbares/cirugía , Masculino , Persona de Mediana Edad , Dimensión del Dolor/métodos , Dolor Postoperatorio/tratamiento farmacológico , Valor Predictivo de las Pruebas , Periodo Preoperatorio , Estudios Prospectivos , Calidad de VidaRESUMEN
BACKGROUND: Biological phenotypes have been identified within several heterogeneous pulmonary diseases, with potential therapeutic consequences. OBJECTIVE: To assess whether distinct biological phenotypes exist within surgical patients, and whether development of postoperative pulmonary complications (PPCs) and subsequent dependence of intra-operative positive end-expiratory pressure (PEEP) differ between such phenotypes. SETTING: Operating rooms of six hospitals in Europe and USA. DESIGN: Secondary analysis of the 'PROtective Ventilation with HIgh or LOw PEEP' trial. PATIENTS: Adult patients scheduled for abdominal surgery who are at risk of PPCs. INTERVENTIONS: Measurement of pre-operative concentrations of seven plasma biomarkers associated with inflammation and lung injury. MAIN OUTCOME MEASURES: We applied unbiased cluster analysis to identify biological phenotypes. We then compared the proportion of patients developing PPCs within each phenotype, and associations between intra-operative PEEP levels and development of PPCs among phenotypes. RESULTS: In total, 242 patients were included. Unbiased cluster analysis clustered the patients within two biological phenotypes. Patients with phenotype 1 had lower plasma concentrations of TNF-α (3.8 [2.4 to 5.9] vs. 10.2 [8.0 to 12.1]âpgâml; Pâ<â0.001), IL-6 (2.3 [1.5 to 4.0] vs. 4.0 [2.9 to 6.5]âpgâml; Pâ<â0.001) and IL-8 (4.7 [3.1 to 8.1] vs. 8.1 [6.0 to 13.9]âpgâml; Pâ<â0.001). Phenotype 2 patients had the highest incidence of PPC (69.8 vs. 34.2% in type 1; Pâ<â0.001). There was no interaction between phenotype and PEEP level for the development of PPCs (43.2% in high PEEP vs. 25.6% in low PEEP in phenotype 1, and 73.6% in high PEEP and 65.7% in low PEEP in phenotype 2; P for interactionâ=â0.503). CONCLUSION: Patients at risk of PPCs and undergoing open abdominal surgery can be clustered based on pre-operative plasma biomarker concentrations. The two identified phenotypes have different incidences of PPCs. Biologic phenotyping could be useful in future randomised controlled trials of intra-operative ventilation. TRIAL REGISTRATION: The PROtective Ventilation with HIgh or LOw PEEP trial, including the substudy from which data were used for the present analysis, was registered at ClinicalTrials.gov (NCT01441791).
Asunto(s)
Mediadores de Inflamación/sangre , Enfermedades Pulmonares/sangre , Fenotipo , Respiración con Presión Positiva/tendencias , Complicaciones Posoperatorias/sangre , Cuidados Preoperatorios/tendencias , Anciano , Biomarcadores/sangre , Análisis por Conglomerados , Femenino , Humanos , Internacionalidad , Enfermedades Pulmonares/diagnóstico , Enfermedades Pulmonares/enzimología , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Cuidados Preoperatorios/métodosRESUMEN
BACKGROUND: Postoperative pulmonary complications (PPCs) are common after major abdominal surgery. The kinetics of plasma biomarkers could improve identification of patients developing PPCs, but the kinetics may depend on intraoperative ventilator settings. OBJECTIVE: To test whether the kinetics of plasma biomarkers are capable of identifying patients who will develop PPCs, and whether the kinetics depend on the intraoperative level of positive end-expiratory pressure (PEEP). DESIGN: A preplanned substudy of a randomised controlled trial. SETTING: Operation room of five centres. PATIENTS: Two hundred and forty-two adult patients scheduled for abdominal surgery at risk of developing PPCs. INTERVENTIONS: High (12âcmH2O) versus low (≤2âcmH2O) levels of PEEP. MAIN OUTCOME MEASURES: Individual PPCs were combined as a composite endpoint. Plasma samples were collected before surgery, directly after surgery and on the fifth postoperative day. The levels of the following were measured: tumour necrosis factor (TNF)-α, interleukin (IL)-6 and IL-8, the soluble form of the Receptor for Advanced Glycation End-products (sRAGE), Surfactant Protein (SP)-D, Clara Cell protein (CC)-16 and Krebs von den Lungen 6 (KL6). RESULTS: Blood sampling was complete in 242 patients: 120 patients in the high PEEP group and 122 patients in the low PEEP group. Increases in plasma levels of TNF- IL-6, IL-8 and CC-16, and a decrease in plasma levels of SP-D were greater in patients who developed PPCs; however, the area under the receiver operating characteristic curve was low for all biomarkers. CC-16 was the only biomarker whose level increased more in patients who had received high levels of PEEP. CONCLUSION: In patients undergoing abdominal surgery and at risk of developing PPCs, plasma levels of biomarkers for inflammation or lung injury showed distinct kinetics with development of PPCs, but none of the biomarkers showed sufficient prognostic value. The use of high levels of PEEP was associated with increased levels of CC-16, suggesting lung overdistension. TRIAL REGISTRATION: The PROVHILO trial, including this substudy, was registered at clinicaltrials.gov (NCT01441791).
Asunto(s)
Mediadores de Inflamación/sangre , Lesión Pulmonar/sangre , Lesión Pulmonar/diagnóstico , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/diagnóstico , Adulto , Biomarcadores/sangre , Femenino , Humanos , Inflamación/sangre , Inflamación/diagnóstico , Inflamación/epidemiología , Lesión Pulmonar/epidemiología , Masculino , Respiración con Presión Positiva/efectos adversos , Respiración con Presión Positiva/tendencias , Complicaciones Posoperatorias/epidemiologíaRESUMEN
BACKGROUND: Pain after surgery is a major issue for patient discomfort and often associated with delayed recovery. The aim of the present study was to evaluate the prevalence of pain and requirement for analgesics up to 6 months after elective surgery, independent if new pain symptoms occurred after surgery or if preoperative pain persisted in the postoperative period. METHODS: A prospective observational single center cohort study was conducted between January 2012 and August 2013. Eligible patients were scheduled to undergo elective surgical interventions including joint (hip, knee arthroplasty), back (nucleotomy, spondylodesis), or urological surgery (cystectomy, prostatectomy, nephrectomy). Pain was assessed on an 11-point numerical rating scale (NRS) before, on postoperative day 2 and 6 months after surgery. Clinical information was collected with structured questionnaires and by telephone interview. RESULTS: Six hundred and forty-four patients gave informed consent, including 54.4 % men (mean age 62.2, SD 14.3). Higher preoperative pain scores were found in patients undergoing joint (mean 7.6; 95 % confidence interval [CI]: 7.2-8.0) and back surgery (mean 7.1, CI: 6.8-7.5) than in patients prior to urological surgery (mean 2.3; CI: 1.8-2.8). After 6 months, about 50 % of patients after joint or back surgery indicated pain levels ≥3/10, compared to 15.9 % of patients after urological surgery (p < .001). 35.3 % of the patients after joint surgery and 41.3 % after back surgery still use pain medication 6 months postoperatively, in contrast to 7.3 % of patients after urological surgery. 13.6 % of patients who underwent back surgery indicated the regular intake of opioids. CONCLUSIONS: Our results reveal that a significant percentage of patients undergoing procedures in joint or back surgery still need pain medication up to 6 months postoperatively due to ongoing pain symptoms. Improved monitoring of pain management is warranted, especially after discharge from hospital, to improve long-term results. TRIAL REGISTRATION: Clinicaltrials.gov (Identifier: NCT01488617 ); date of registration December 6th 2011.
Asunto(s)
Analgésicos/administración & dosificación , Dolor Crónico/epidemiología , Procedimientos Quirúrgicos Electivos/efectos adversos , Dolor Postoperatorio/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/administración & dosificación , Dolor Crónico/tratamiento farmacológico , Dolor Crónico/etiología , Estudios de Cohortes , Procedimientos Quirúrgicos Electivos/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Dolor Postoperatorio/tratamiento farmacológico , Periodo Preoperatorio , Prevalencia , Estudios Prospectivos , Encuestas y Cuestionarios , Factores de Tiempo , Adulto JovenRESUMEN
BACKGROUND: Preoperative anxiety and need for information can be detected during preoperative consultation via structured and standardised screening by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire. OBJECTIVE: To identify the prevalence of preoperative anxiety and need for information, with regard to influencing factors such as age, sex, previous operation and grade of surgery, and to examine the level of agreement between patients' self-rating and physicians' ratings. DESIGN: Prospective observational study. SETTING: Department of Anaesthesiology, University Medical Centre of the Johannes Gutenberg University Mainz, Germany. PATIENTS: Two hundred seventeen patients scheduled for elective surgery. INTERVENTIONS: The patients completed questionnaires prior to the interaction with the anaesthesiologist. Physicians were blinded to the patients' ratings and provided their subjective ratings about patients' anxiety and need for information immediately after seeing the patient. MAIN OUTCOME MEASURE: Degree of anxiety and need for information, agreement of patients' self-reports and physician's rating. RESULTS: 18.9% of patients were classified as 'anxiety cases' (31.8% in women and 10.6% in men). The grade of the intended surgery but no other investigated factor was related to patients' anxiety. Age (older patients) was correlated with information requirement (râ=â0.21, Pâ=â0.002). Analysis of agreement showed only weak correlations between patients' self-reports and physicians' ratings, demonstrated in low weighted Kappa-coefficients (0.12 to 0.32). CONCLUSION: The APAIS is a useful instrument to assess the level of patients' preoperative anxiety and the need for information. Given the relationship between preoperative anxiety and postoperative outcome, it seems justified to incorporate this approach into the preoperative consultation. TRIAL REGISTRATION: German Clinical Trials Register DRKS00003084.
Asunto(s)
Ansiedad/diagnóstico , Procedimientos Quirúrgicos Electivos/psicología , Cuidados Preoperatorios/métodos , Encuestas y Cuestionarios , Adulto , Factores de Edad , Anciano , Ansiedad/etiología , Femenino , Alemania , Necesidades y Demandas de Servicios de Salud , Humanos , Masculino , Persona de Mediana Edad , Médicos , Estudios Prospectivos , AutoinformeRESUMEN
Post-operative pain management of elderly patients requires special attention. In addition to the organic functional impairments, age-related changes in psychological and social factors play an important role. Also life experiences, painful medical history and a range of different complaints of old age influence the expectations to the treatment of pain. Several factors have to be considered, so 1) age-appropriate preoperative assessment of organic, psychological and social factors, 2) a selection of regularly administered non-opioid, or combination of two different effective non-opioids, notably on the contra-indications and dose limits, 3) if necessary careful titration of the strong opioid with patient adjustment further doses in the recovery room ("start low, go slow"), 4) if necessary, supplement the non-opioid with a strong, not retarded opioid (subcutaneous or oral administration) on the ward, 5) restrictive indication for retarded opioids because of increased risk to fall and constipation, 6) more frequent control of side effects than for younger patients, 7) medical care with increased acceptance of autonomy, to allow trust to improve the often limited compliance and to achieve high patient satisfaction.
Asunto(s)
Analgésicos/uso terapéutico , Evaluación Geriátrica/métodos , Manejo del Dolor , Dimensión del Dolor/tendencias , Dolor/diagnóstico , Psicoterapia/tendencias , Apoyo Social , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Femenino , Humanos , MasculinoRESUMEN
BACKGROUND: Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have less compensatory mechanisms because of multiple co-morbidities and age-related decline of functional reserves. The purpose of the study is to evaluate whether elderly surgical patients may benefit from a liberal red blood cell (RBC) transfusion strategy compared to a restrictive transfusion strategy. METHODS: The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2470 elderly (≥ 70 years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches ≤9 g/dl during surgery or within 3 days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb ≤ 9 g/dl with a target range for the post-transfusion Hb level of 9-10.5 g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb ≤ 7.5 g/dl with a target range for the post-transfusion Hb level of 7.5-9 g/dl). The intervention per patient will be followed until hospital discharge or up to 30 days after surgery, whichever occurs first. The primary efficacy outcome is defined as a composite of all-cause mortality, acute myocardial infarction, acute ischaemic stroke, acute kidney injury (stage III), acute mesenteric ischaemia and acute peripheral vascular ischaemia within 90 days after surgery. Infections requiring iv antibiotics with re-hospitalisation are assessed as important secondary endpoint. The primary endpoint will be analysed by logistic regression adjusting for age, cancer surgery (y/n), type of surgery (intermediate- or high-risk), and incorporating centres as random effect. DISCUSSION: The LIBERAL-Trial will evaluate whether a liberal transfusion strategy reduces the occurrence of major adverse events after non-cardiac surgery in the geriatric population compared to a restrictive strategy within 90 days after surgery. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03369210 ).
Asunto(s)
Anemia/terapia , Transfusión de Eritrocitos/métodos , Isquemia/prevención & control , Atención Perioperativa/métodos , Procedimientos Quirúrgicos Operativos , Factores de Edad , Anciano , Anciano de 80 o más Años , Anemia/sangre , Anemia/complicaciones , Anemia/mortalidad , Biomarcadores/sangre , Causas de Muerte , Ensayos Clínicos Fase IV como Asunto , Transfusión de Eritrocitos/efectos adversos , Transfusión de Eritrocitos/mortalidad , Femenino , Alemania , Hemoglobinas/metabolismo , Humanos , Isquemia/sangre , Isquemia/diagnóstico , Isquemia/etiología , Masculino , Estudios Multicéntricos como Asunto , Readmisión del Paciente , Atención Perioperativa/efectos adversos , Atención Perioperativa/mortalidad , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Procedimientos Quirúrgicos Operativos/efectos adversos , Procedimientos Quirúrgicos Operativos/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Rotating several different WHO level III opioid drugs is a therapeutic option for patients with chronic cancer-related pain who suffer from inadequate analgesia and/or intolerable side effects. The evidence favoring opioid rotation is controversial, and the current guidelines in Germany and other countries contain only weak recommendations for it. METHODS: This review is based on pertinent publications retrieved by a systematic review of the literature on opioid rotation for adult patients with chronic cancerrelated pain who are regularly taking WHO level III opioids by the oral or trans - dermal route. RESULTS: 9 individual studies involving a total of 725 patients were included in the analysis, and 3 previous systematic reviews of studies involving a total of 2296 patients were also analyzed. Morphine, oxycodone, fentanyl, hydromorphone, and buprenorphine were used as first-line opioid drugs, and hydromorphone, bupre - norphine, tapentadol, fentanyl, morphine, oxymorphone, and methadone were used as second-line opioid drugs. In all of the studies, pain control was achieved for 14 days after each rotation. In most of them, the dose of the new drug introduced in each rotation needed to be increased above the dose initially calculated from a rotation ratio, with the exception of rotations to methadone. The frequency of side effects was only rarely lessened, but patients largely considered the result of opioid rotation to be positive. No particular opioid drug was found to be best. CONCLUSION: Opioid rotation can improve analgesia and patient satisfaction. The success of opioid rotation appears to depend on the magnitude of the initial dose, among other factors. Tables of equianalgesic doses should be considered no more than a rough guide for determining the dose of the new drug. Rotations to methadone should be carried out under clinical supervision in experienced hands.
Asunto(s)
Analgésicos Opioides/administración & dosificación , Dolor en Cáncer/tratamiento farmacológico , Manejo del Dolor/métodos , Analgésicos Opioides/uso terapéutico , Buprenorfina/administración & dosificación , Buprenorfina/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Fentanilo/administración & dosificación , Fentanilo/uso terapéutico , Alemania , Humanos , Hidromorfona/administración & dosificación , Hidromorfona/uso terapéutico , Morfina/administración & dosificación , Morfina/uso terapéutico , Neoplasias/complicaciones , Oxicodona/administración & dosificación , Oxicodona/uso terapéutico , Manejo del Dolor/normasRESUMEN
INTRODUCTION: Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse. METHODS AND ANALYSIS: The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60. ETHICS AND DISSEMINATION: iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals. TRIAL REGISTRATION NUMBER: DRKS00013644; Pre-results.
Asunto(s)
Anestesia General/métodos , Anestesia Raquidea/métodos , Protocolos de Ensayos Clínicos como Asunto , Fracturas de Cadera/cirugía , Complicaciones Posoperatorias/prevención & control , Anciano , Artroplastia de Reemplazo de Cadera , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Dolor Postoperatorio/prevención & control , Ensayos Clínicos Pragmáticos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de InvestigaciónRESUMEN
BACKGROUND: Remote ischemic preconditioning (RIPC) has been suggested to protect against certain forms of organ injury after cardiac surgery. Previously, we reported the main results of RIPHeart (Remote Ischemic Preconditioning for Heart Surgery) Study, a multicenter trial randomizing 1403 cardiac surgery patients receiving either RIPC or sham-RIPC. METHODS AND RESULTS: In this follow-up paper, we present 1-year follow-up of the composite primary end point and its individual components (all-cause mortality, myocardial infarction, stroke and acute renal failure), in a sub-group of patients, intraoperative myocardial dysfunction assessed by transesophageal echocardiography and the incidence of postoperative neurocognitive dysfunction 5 to 7 days and 3 months after surgery. RIPC neither showed any beneficial effect on the 1-year composite primary end point (RIPC versus sham-RIPC 16.4% versus 16.9%) and its individual components (all-cause mortality [3.4% versus 2.5%], myocardial infarction [7.0% versus 9.4%], stroke [2.2% versus 3.1%], acute renal failure [7.0% versus 5.7%]) nor improved intraoperative myocardial dysfunction or incidence of postoperative neurocognitive dysfunction 5 to 7 days (67 [47.5%] versus 71 [53.8%] patients) and 3 months after surgery (17 [27.9%] versus 18 [27.7%] patients), respectively. CONCLUSIONS: Similar to our main study, RIPC had no effect on intraoperative myocardial dysfunction, neurocognitive function and long-term outcome in cardiac surgery patients undergoing propofol anesthesia. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01067703.
Asunto(s)
Procedimientos Quirúrgicos Cardíacos/efectos adversos , Cognición , Precondicionamiento Isquémico Miocárdico/métodos , Infarto del Miocardio/epidemiología , Daño por Reperfusión Miocárdica/epidemiología , Trastornos Neurocognitivos/epidemiología , Anestésicos Intravenosos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Método Doble Ciego , Ecocardiografía Transesofágica , Alemania/epidemiología , Humanos , Incidencia , Precondicionamiento Isquémico Miocárdico/efectos adversos , Precondicionamiento Isquémico Miocárdico/mortalidad , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/prevención & control , Daño por Reperfusión Miocárdica/diagnóstico por imagen , Daño por Reperfusión Miocárdica/prevención & control , Trastornos Neurocognitivos/diagnóstico , Trastornos Neurocognitivos/prevención & control , Trastornos Neurocognitivos/psicología , Pruebas Neuropsicológicas , Propofol/efectos adversos , Estudios Prospectivos , Factores Protectores , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Undergraduate palliative care education (UPCE) became mandatory in Germany by 2013. The training in Mainz, addressing fifth-year (5Y) medical students, emphasizes transfer of knowledge and skills. In this study we assessed students' knowledge and students' self-estimation of self-confidence in palliative care (PC) according to Bandura's concept of self-efficacy. OBJECTIVE: The study objective was to evaluate the effects of the Mainz UPCE on students' self-confidence regarding important domains in PC. METHODS: We conducted a prospective questionnaire-based cohort study with a pre-post design. 5Y medical students (n=329) were asked for self-estimation concerning knowledge, somatic aspects, spiritual and psychological aspects before and after a 7x90-minute teaching course. To assess knowledge, students completed a multiple choice examination at the end of the term. RESULTS: Overall, 156 students completed matched surveys at both points of measurement. The majority of these students felt more confident after the course than before in all aspects of PC (p<0.0001). All students passed the exam with average scores greater than 90%. CONCLUSION: A 7x90-minute interactive tutorial in PC for 5Y medical students is feasible and improves both self-efficacy and knowledge of core PC issues. Whether the effects of the course are long-lasting is the objective for further research.