Major incidents and complications in otherwise healthy patients undergoing elective procedures: results based on 1.37 million anaesthetic procedures.

BACKGROUND: Improved anaesthesia safety has made severe anaesthesia-related incidents, complications, and deaths rare events, but concern about morbidity and mortality in anaesthesia continues. This study examines possible severe adverse outcomes or death recorded in a large national surveillance system based on a core data set (CDS). METHODS: Cases from 1999 to 2010 were filtered from the CDS database. Cases were defined as elective patients classified as ASA physical status grades I and II (without relevant risk factors) resulting in death or serious complication. Four experts reviewed the cases to determine anaesthetic involvement. RESULTS: Of 1 374 678 otherwise healthy, ASA I and II patients in the CDS database, 36 met the study inclusion criteria resulting in a death or serious complication rate of 26.2 per million [95% confidence interval (CI), 19.4-34.6] procedures, and for those with possible direct anaesthetic involvement, 7.3 per million cases (95% CI, 3.9-12.3). CONCLUSIONS: This is the first study assessing severe incidents and complications from a national outcome-tracking database. Annual identification and review of cases, perhaps with standardized database queries in the respective departments, might provide more detailed information about the cascades that lead to unfortunate outcomes.

Epidemiology of acute renal failure and outcome of haemodiafiltration in intensive care.

OBJECTIVE: To examine the epidemiology of acute renal failure (ARF) and to identify predictors of mortality in patients treated by continuous venovenous haemodiafiltration (CVVHDF). DESIGN: Uncontrolled observational study. SETTING: One intensive care unit (ICU) at a surgical and trauma centre. PATIENTS: A consecutive sample of 3591 ICU treatments. MEASUREMENTS AND RESULTS: Demographic data, indications for ICU admission, severity scores and organ system failure at the beginning of CVVHDF were set against the occurrence of ARF and ICU mortality. 154 (4.3% of ICU patients and 0.6% of the hospital population) developed ARF and were treated with CVVHDF. Higher American Society of Anaesthesiologists (ASA) status and higher Apache II score were associated with ICU incidence of ARF. However, these criteria were not able to predict outcome in ARF. A simplified predictive model was derived using multivariate logistic regression modelling. The mortality rates were 12% with one failing organ system (OSF), 38% with two OSF, 72% with three OSF, 90% with four OSF and 100% with five OSF. The adjusted odds ratio (OR) of death was 7.7 for cardiovascular failure, 6.3 for hepatic failure, 3.6 for respiratory failure, 3.0 for neurologic failure, 5.3 for massive transfusion and 3.7 for age of 60 years or more. CONCLUSION: General measures of severity are not useful in predicting the outcome of ARF. Only the nature and number of dysfunctioning organ systems and massive transfusion at the beginning of CVVHDF and the age of the patients gave a reliable prognosis in this group of patients.

Release of endogenous vasopressors during and after cardiopulmonary resuscitation.

OBJECTIVE: To assess whether plasma endothelin, adrenaline, noradrenaline, arginine vasopressin, adrenocorticotropin, and cortisol concentrations were higher during cardiopulmonary resuscitation in patients in whom resuscitation was successful than in those in whom it failed, and to measure the concentrations of these hormones in the immediate post-resuscitation phase. DESIGN: Prospective, descriptive study. SETTING: Emergency medical service at a university hospital. PATIENTS: 60 patients with cardiac arrest out of hospital. INTERVENTIONS: Blood samples were drawn and blood pressure and heart rate were measured during cardiopulmonary resuscitation, before and after the first dose of adrenaline was given and at 5, 15, 30, and 60 minutes after the restoration of spontaneous circulation. Plasma hormone concentrations were measured by radio-immunoassays. RESULTS: 24 of the 60 patients were successfully resuscitated and admitted to hospital: 36 were not. During cardiopulmonary resuscitation before adrenaline was given, the plasma concentration of endothelin (mean (SEM)) in resuscitated and in not resuscitated patients was 4.3 (0.9) pg/ml and 5.5 (0.4) pg/ml respectively (NS), adrenaline was 14.1 (2.0) ng/ml and 25.3 (3.6) ng/ml (P < 0.01), noradrenaline was 5.0 (0.9 ng/ml) and 8.4 (1.1 ng/ml) (P < 0.05), arginine vasopressin was 193 (28) pg/ml and 70 (9) pg/ml (P < 0.001), adrenocorticotropin was 128 (34) pg/ml and 57 (6) pg/ml (P < 0.05), and cortisol was 18 (3) microgram/dl and 15 (2) microgram/dl (NS). During cardiopulmonary resuscitation after adrenaline was given endothelin in resuscitated and in not resuscitated patients was 4.0 (1.0) pg/ml and 5.3 (0.5) pg/ml (NS), adrenaline was 145 (16) ng/ml and 201 (21) ng/ml (P < 0.05), noradrenaline was 3.9 (0.9) ng/ml and 8.3 (1.1) ng/ml (P < 0.01), arginine vasopressin was 177 (27) pg/ml and 58 (9) pg/ml (P < 0.001), adrenocorticotropin was 234 (92) pg/ml and 85 (9) pg/ml (P < 0.001), and cortisol was 17 (2) microgram/dl and 13 (2) microgram/dl (NS). CONCLUSIONS: Despite a tremendous adrenosympathetic response, the lower arginine vasopressin and adrenocorticotropin concentrations during cardiopulmonary resuscitation in patients in whom resuscitation failed may influence vital organ perfusion and hence the success of resuscitation. Plasma concentrations of arginine vasopressin and adrenocorticotropin may have a more important effect on outcome than previously thought.

Effects of epinephrine and vasopressin on median fibrillation frequency and defibrillation success in a porcine model of cardiopulmonary resuscitation.

OBJECTIVE: This study was designed to assess whether median frequency of ventricular fibrillation (VF) correlates with myocardial blood flow and defibrillation success during cardiopulmonary resuscitation (CPR) after epinephrine or vasopressin administration. METHODS AND RESULTS: After 4 min of VF and 3 min of CPR, 14 pigs received 0.045 mg/kg epinephrine or 0.4 U/kg vasopressin. Using radio-labeled microspheres, median myocardial blood flow during CPR before, and 90 s and 5 min after drug administration (DA) was 15.5 (12.6, 23.1; 25th percentile, 75th percentile), 26.4 (18.5, 29.1), 16.9 (14.9, 19.1) mL min-1 100 g-1, respectively, in the epinephrine, and 16.9 (15.4, 18.9), 48.1 (36.9, 68.9) (P < 0.05 vs. before DA), 52.3 (38.5, 65.0) mL min-1 100 g-1, respectively, in the vasopressin group. Using spectral analysis of VF, median frequency of VF was 11.0 (10.7, 11.8), 11.3 (9.6, 13.1), 10.2, (8.8, 11.4) Hz, respectively, in the epinephrine, and 10.1 (10.0, 10.5), 11.7 (11.1, 14.2) (P < 0.05 vs. before DA), 13.2 (11.5, 13.9) Hz, respectively, in the vasopressin group at the same points in time. Median frequency correlates significantly with myocardial blood flow in the epinephrine (n = 21); rs = 0.772; P < 0.001) and in the vasopressin group (n = 21; rs = 0.905; P < 0.001). Median fibrillation frequency before the first defibrillation was 13.0 (12.2, 13.2) Hz in resuscitated (n = 8) and 9.2 (8.3, 10.2) Hz (n = 6) in non-resuscitated animals (P < 0.01). CONCLUSIONS: We conclude that median frequency of VF reflects myocardial blood flow and the chance of successful defibrillation during closed-chest CPR after vasopressor treatment in a porcine model of VF.

Interaction modeling of propofol and sufentanil on loss of consciousness.

STUDY OBJECTIVES: To examine the possible pharmacodynamic interaction of propofol and sufentanil with respect to the induction of loss of consciousness. DESIGN: Prospective, randomized, double-blinded study. SETTING: University hospital. PATIENTS: 30 female, ASA physical status I and II patients undergoing elective gynecologic surgery. INTERVENTIONS: Patients were allocated randomly to receive an individual combination of propofol (1, 2, 3, 4, 5, or 6 micrograms/ml) and sufentanil (0.1, 0.2, 0.3, 0.5, or 1.0 ng/ml) target blood concentrations using target-controlled infusions. MEASUREMENTS AND MAIN RESULTS: Study endpoint was loss of consciousness, which was tested by response to verbal commands and classified as responder or nonresponder, as assessed by the anesthetist, who was blinded to the drugs' target blood concentrations. Nonlinear association (interaction) of both drugs was accomplished with logistic regression analysis using the maximum likelihood method, based principally on the hypothesis of interaction: In [p/(1-p)] = beta 0 + beta 1 x Cprop + beta 2 x Csuf + beta 3 x Cprop x Csuf with a p-value < 0.05 for coefficient estimates considered significant. In the logistic regression model, sufentanil and propofol showed no supra-additive interaction regarding loss of consciousness (p = 0.5916). CONCLUSIONS: Our results give no evidence of additional hypnotic properties of sufentanil compared to the other fentanyl congeners, although logistic regression may be of limited value in modeling interaction of hypnotic-analgesic combinations.

[Clinical practice improvement--clinical practice quality improvement of local health care processes]. / Clinical Practice Improvement--Qualitätsverbesserung lokaler medizinischer Versorgungsprozesse.

Clinical Practice Improvement (CPI) is a methodological approach to develop analytically-based protocols to achieve desirable outcomes at the lowest essential cost over the continuum of local care processes. Several elements of the CPI approach make it attractive to clinicians: First, it is a scientific bottom-up approach that places accountability for practice improvement and outcomes with local clinicians. Clinicians are not told to blindly follow a guideline or protocol developed by others, but instead collect data on outcomes, on treatments, and on patient signs and symptoms that support practice change. CPI supports caregivers in making their own decisions about optimal care on the basis of objective statistical evidence gathered in the routine, everyday practice of medicine. Second, CPI measurement encompasses a comprehensive view of the care management process: patient characteristics, process steps, and outcomes. All three classes of data are considered simultaneously. This comprehensive measurement framework provides a basis for meaningful analyses of significant associations, as well as relationships between process and outcome. Third, the CPI methodology focuses on deployment and application. There is a continual emphasis on factors that can be implemented to improve outcomes and the process to achieve these results. This focus on implementation guides who is involved in the design, what data are collected, what questions are answered during analyses, and who designs the protocols or improvements in practice.

[Comparison of 5% human albumin and 6% 200/0.5 HES as exclusive colloid components in large surgical interventions]. / Vergleich von Humanalbumin 5% und 6% HES 200/0.5 als ausschliessliche Kolloidkomponente bei grossen chirurgischen Eingriffen.

OBJECTIVE: It was the purpose of the following study to compare effects of 6% hydroxyethyl starch 200/0.5 (HES) and albumin 5% (HA5) on haemostasis, haemodynamics, oncotic function and plasmatic homoeostasis. METHODS: In 2 randomised groups of 20 patients each undergoing large surgery (criteria of exclusion: anaemia, renal, liver, and coagulation disorders, ASA classification > III) we treated up to 1000 ml with colloid solution, from 1000 ml up to 5000 ml with packed red blood cells (PRBC) and colloid solution (1:1) and above 5000 ml with PRBC and fresh frozen plasma (1:1). Group HES received HES and group HA5 albumin as exclusive colloid component and both continuously lactated Ringers' at a rate of 500 ml/h. We measured the parameters before operation, after each 1000 ml colloid up to 3000 ml application and at the end of operation and we registered total blood output/intake. RESULTS: We found comparable amounts of blood loss and blood intake (mean total amount of colloid solution: HES 2044 +/- 579 ml; HA5 2547 +/- 980 ml). We didn't find any differences in haemodynamics nor in haematocrit, platelets or global coagulation parameters which only showed dilutional influences. Differences existed in total serum protein (HES 32.8 +/- 6.5 gr/l; HA5 54 +/- 5.5 gr/l at OP's end); however COP was maintained in both groups during the whole study period at normal ranges. Plasmatic haemostasis showed to a large extent corresponding values. Remarkable was the development of a metabolic acidosis in the HA5 group. CONCLUSION: Regarding total blood output/intake, haemodynamic functions, haematological parameters, coagulation, oncotic function, and plasmatic homoeostasis, HES is a safe colloid if contra-indications are taken into account, capable of replacing albumin 5% entirely as a colloid component of treatment of even large blood losses intraoperatively above the recommended dose of 20 ml/kg BW/d.

Building a large-scale perioperative anaesthesia outcome-tracking database: methodology, implementation, and experiences from one provider within the German quality project.

The German Society of Anaesthesiology and Intensive Care Medicine evaluates voluntary, standardized, everyday, perioperative anaesthesia outcome measures. A standard minimal data set is collected for national benchmarking. This article reviews the implementation of a data acquisition system in one academic centre that has participated in this long-term nationwide project since its initiation in 1992. The population studied comprised 96,107 patients up to 1997. The overall incidence of anaesthesia-related incidents, events and complications (IEC) was 22%. Results are presented and discussed for 63 different IEC, seven functional system categories and five severity grades. The proposed methodology, using computer-readable records, was suitable for comprehensive and detailed outcome documentation. However, an extensive data validation system was necessary. IEC reporting results were largely dependent on the documentation culture. The future of outcome tracking in routine anaesthesia may lie in multicentre comparisons with multivariate-adjusted risk and comorbidity data from each provider's integrated information system.

The impact of minor perioperative anesthesia-related incidents, events, and complications on postanesthesia care unit utilization.

UNLABELLED: The German Society of Anesthesiology and Intensive Care Medicine evaluates the standardized and routine reporting of perioperative anesthesia-related incidents, events, and complications (IEC). As part of the long-term project's definitions, IECs are graded according to severity and to their clinical consequence on further postanesthesia monitoring and treatment demands. The adult study population of our department comprised 37,079 patients recovering from anesthesia in a tertiary university hospital from July 1992 through June 1997. Cardiac, obstetric, craniotomy, thoracotomy, laparotomy, and emergency operations were excluded. Multivariate regression statistics were used to calibrate the impact of minor graded IECs on necessary postanesthesia care unit (PACU) utilization. Minor and severe IECs appeared in 22.1% and 0.2% of the patients. A minor IEC occurrence was a statistically significant (P < 0.001) predictor of PACU utilization in a multivariate regression model. The mean difference of PACU length of stay for patients with minor IECs was prolonged by a range of 6%-26% when adjusted for coexisting severity features such as age, gender, ASA physical status, and type and duration of anesthesia and surgery. We conclude that the IEC methodology integrates epidemiologic information about perioperative anesthesia outcome. Minor but frequently occurring IECs have an impact on PACU utilization and are thus important to measure and follow. IMPLICATIONS: It is desirable to know how anesthesia-related incidents, events, and complications influence postanesthesia care. Analyses of standardized and routine perioperative outcome data, as proposed by the German anesthesia quality project, can show that even minor events consume relevant resources and are thus important to measure and follow.

Validation of routine incidence reporting of one anaesthesia provider institution within a nation-wide quality of process assessment program.

In 1992, a long-term project was launched by the German Society for Anaesthesiology and Intensive Care Medicine to render quality comparisons between anaesthesia providers. As one of the first volunteer centres, we established the standardised reporting of perioperative anaesthesia related incidents, events, and complications (IEC) in any routine anaesthetic procedure performed. This present study is aimed to explore the longitudinal stability of IEC recordings in one institution, which should be a prerequisite for valid external comparisons. Methods. The analyses were completed on an adult population of 49945 consecutive anaesthetic procedures with peripheral surgery from July 1992 until December 1996. Attribute quality control charts with monthly samples of an average of 954 anaesthetics were used to assess statistical variability of specific IEC incidences. Results. Average proportions were 20% for moderate IEC, 2.7% for severe IEC, 13% for moderate cardio-vascular IEC, 1.3% for severe cardio-vascular IEC, and 2.4% for respiratory IEC. Moderate IEC proportions showed considerable variability during the study period. A series of excess proportions was probably due to educational activities on documentation discipline. In contrast, clinically severe IEC proportions were rather stable. Stability of cardio-vascular IEC proportions resembled the picture of the overall IEC assessment. Monthly respiratory IEC proportions showed smallest variability during the study period. Discussion. Use of the quality control statistics is suitable to distinguish random from systematic influence on quality indicators. IEC recordings that are not specific in pathophysiologic type or are of low grade of clinical severity, are heavily dependent on systematic documentation features. We assume that peak values, such as in times of optimised documentation discipline, better reflect reality than average values because missing reporting is much more likely than false positives.

Perioperative respiratory events in smokers and nonsmokers undergoing general anaesthesia.

BACKGROUND: The prevalence of respiratory diseases in smokers and nonsmokers and the incidence of perioperative respiratory events (PREs) were investigated for patients undergoing general anaesthesia. The aim was to quantify well-known problems and to identify possible new associations between smoking and PREs. METHODS: From July 1992 to December 1994, risk factors, demographic data, and PREs were documented by an automatically readable anaesthetic record (ARAR). PREs were used as defined by the German Society of Anaesthesiology and Intensive Care. RESULTS: Of 26961 subsequent anaesthesias in adults, 7122 (26.4%) were performed in smokers with a prevalence of chronic bronchitis of 23.3% (4.8% in nonsmokers). 1573 PREs occurred in 1397 (5.2%) of all anaesthetics. 459 events concerned intubation problems and problems in technical airway management. 1114 specific respiratory events (SPREs) like re-intubation, laryngospasm, bronchospasm, aspiration, hypoventilation/hypoxaemia and others had a total incidence of 5.5% in smokers and 3.1% in nonsmokers. The relative risk (RR) of SPREs was 1.8 in all smokers, 2.3 in young (16-39 years) smokers, and 6.3 in obese young smokers. The RR of perioperative bronchospasm was 25.7 in young smokers with chronic bronchitis. CONCLUSION: The impact of smoking on perioperative respiratory problems should make anaesthetists take this widespread preoperative condition seriously, particularly in young adults. The presented method of incident reporting (based on a national classification) could contribute to future research in anaesthetic epidemiology.

Assessment of the safety and tolerance of 6% hydroxyethyl starch (200/0.5) solution: a randomized, controlled epidemiology study.

UNLABELLED: None of the natural and synthetic colloids currently available is free from the risk of side effects. This study was performed to contribute to the epidemiology of adverse reactions of the widely used 200/0.5 hydroxyethyl starch 6% solution (HES). Study end points were anaphylactoid reactions during preanesthesia infusion and perioperative course, and pruritus 5 days postoperatively (clinical examination and inquiry) and 8 wk after application (mailed patient questionnaire). We consecutively randomized 750 patients undergoing minor elective surgery into two parallel groups treated with HES (from two different manufacturers) and one control group treated with lactated Ringer's solution. The study population was well matched among the groups and consisted of patients of both sexes, aged 18-95 yr, ASA physical status I-III. No drug-related anaphylactoid reactions were detected during either of the observation intervals. There was no episode of pruritus after the fifth postoperative day. Incidence of pruritus after 8 wk was quite frequent but not significantly different (chi2 test, P = 0.77): 9.1% and 12.0% in the two HES groups and 11.5% in the lactated Ringer's solution control group. Except for pruritus, we conclude that HES was associated with no more complications than lactated Ringer's solution. IMPLICATIONS: Anaphylactoid reactions and pruritus (itching) after the administration of a 6% hydroxyethyl starch (200/0.5) versus lactated Ringer's solution were assessed in a prospective, randomized, controlled study. There were no differences, although there was a more than 10% incidence of pruritus in both groups.

Clinical utility of EEG parameters to predict loss of consciousness and response to skin incision during total intravenous anaesthesia.

We studied 30 female patients undergoing elective surgery, to assess the reliability of electroencephalogram spectral edge frequency and median frequency to predict loss of consciousness and movement in response to skin incision during total intravenous anaesthesia. Each patient received a different combination of propofol (1, 2, 3, 4, 5 or 6 micrograms.ml-1) and sufentanil (0.1, 0.2, 0.3, 0.5 or 1.0 ng.ml-1) target concentrations for induction of anaesthesia using target controlled infusions, assigned randomly. In a logistic regression model, spectral edge frequency was a significant determinant of both loss of consciousness (p = 0.0006) and movement to skin incision (p = 0.0044), whereas for median frequency no significant prediction model could be established. The probabilities of 50% and 95% no response for spectral edge frequency were 13.4 Hz and 6.8 Hz, respectively. The variability of the data limited the predictive value, so that spectral edge frequency was a poor predictor and median frequency was no predictor of response in the individual patient during total intravenous propofol/sufentanil anaesthesia.

[The incidence of perioperative events with optimized documentation discipline]. / Inzidenz perioperativer Ereignisse bei optimierter Dokumentationsdisziplin.

AIM: The German Society of Anesthesiology and Intensive Care Medicine evaluated the standardized reporting of perioperative anaesthesia-related incidents, events, and complications (IEC). As part of the data validation efforts, the problem of variation in documentation procedure was evaluated. METHODS: A study group of particularly motivated and instructed residents and attendants was scrutinized at a University teaching hospital from April through June 96. IEC assessment was completed according to the Society's definitions. RESULTS: Out of 4242 anaesthetics during the study period 839 (19.8%) were completed by the study group. In the univariate analysis, the incidence of IECs was significantly (P < 0.001) more reported by the physicians studied (36.4%) than by the control group (18.6%). In a multivariate analysis, while adjusting for all covariables, reported incidence of IEC was 2.4-fold significantly increased (P < 0.001). CONCLUSIONS: This study is another step in validating the assessment of IECs. The results gain importance with respect to upcoming nationwide quality comparisons among anaesthesia providers. In addition, they give a better estimate of economic implications from IECs within the institution.

[The balanced scorecard. "Tool or toy" in hospitals]. / Balanced Scorecard. "Tool or toy" im Krankenhaus?

The change in hospital funding with diagnosis related groups (DRG), medical advances as well as demographic changes will call for new quantitative and qualitative standards imposed on German hospitals. Increasing costs and competition in the health care sector requires new and innovative strategies for resource management. Today's policy is mainly defined by rationing and intensified workload. The introduction of DRGs will presumably further constrict management perspectives on pure financial aspects. However, to ensure future development, compassionate services and continued existence of hospitals, a balance of seemingly conflicting perspectives, such as finance, customer, process, learning and growth are of utmost importance. Herein doctors and nurses in leading positions should play a key role in changing management practice. For several years the balanced scorecard has been successfully used as a strategic management concept in non-profit organizations, even in the health care sector. This concept complies with the multidimensional purposes of hospitals and focuses on policy deployment. Finally it gives the opportunity to involve all employees in the original development, communication and execution of a balanced scorecard approach.

Droperidol and 5-HT3-receptor antagonists, alone or in combination, for prophylaxis of postoperative nausea and vomiting. A meta-analysis of randomised controlled trials.

BACKGROUND: Droperidol and 5-HT3-receptor antagonists are among the most potent antiemetics to prevent postoperative nausea and vomiting (PONV). Combinations of these drugs have been used to increase the efficacy of antiemetic treatment. However, so far the quantitative effect of this combination has not been evaluated systematically. METHODS: Results from randomised controlled trials investigating the efficacy of 5-HT3-receptor antagonists or droperidol alone versus the combination of both drugs to prevent PONV were included in a meta-analysis. Studies were systematically searched using Medline, EMBASE, the Cochrane-Library, and by manually screening the reference lists of matching review articles and current issues of locally available peer-reviewed anaesthesia journals. Seven papers with data on granisetron published by Fujii and co-workers were not considered. The main end point in each study was defined as occurrence of nausea, retching, or vomiting within 6 h ("early PONV") and within 48 h ("late PONV") after surgery. The relative risks (RR) and the numbers needed to treat (NNT) of the pooled data with their corresponding 95% confidence intervals (given in parentheses) were calculated using a random effects model. RESULTS: Eight studies with 881 patients (adults: n=801; children (mean age: 8 yr): n=80) were included in the analysis. Droperidol was applied to 340 patients, 5-HT3-receptor antagonists to 198, and 343 were treated with a combination of both drugs. Seven out of these eight studies reported increased antiemetic efficacy of the combination group compared with the single drugs (droperidol and 5-HT3-receptor antagonists respectively). However, in none of the trials did this difference reach statistical significance. When a meta-analytic analysis based on these results was performed the combination of droperidol with a 5-HT3-receptor antagonist was not associated with a significantly increased antiemetic efficacy. In 12 to 13 patients a 5-HT3-receptor antagonist has to be added to droperidol prophylaxis to prevent one additional patient from PONV who would have had suffered from PONV when treated with droperidol alone (RR "early PONV": 1.52 (0.95-2.44); RR "late PONV": 1.24 (0.89-1.74)). Similar results were obtained when the antiemetic effect of adding droperidol to a prophylaxis with 5-HT3-receptor antagonists was analysed. In this case 10 to 12 patients have to be treated with the 5-HT3-droperidol combination instead of with a 5-HT3-receptor antagonist alone to prevent one additional patient from PONV (RR "early PONV": 1.55 (0.68-3.52); RR "late PONV": 1.29 (0.77-2.17)). There were no reports of an increased incidence of adverse effects. CONCLUSION: The data on the combination of droperidol with 5-HT3-receptor antagonists suggest that there is a trend towards increased efficacy of the combination therapy compared to the single drugs. However, so far there are insufficient data to recommend this combination treatment for prophylaxis.

[Perioperative monitoring of the course of anesthesia, the postanesthesia visit and inquiry of patient satisfaction. A prospective study of parameters in process and outcome quality in anesthesia]. / Perioperative Anästhesieverlaufsbeobachtungen, postanästhesiologische Visite und Befragung zur Patientenzufriedenheit.Eine prospektive Studie zu Parametern der Prozess und Ergebnisqualität in der Anästhesie.

PURPOSE: This study is an investigation into the results of reporting on incidents during and after anaesthesia, to reveal any possible associations between intra-procedural and final outcome. The study contributes to the quality assurance project of the German Society of Anaesthesiology and Intensive Care (DGAI). We adjusted and tabulated our data for preoperative risk and for different methods of anaesthesia. This nation-wide DGAI project was launched to compare clinical institutions in accordance with German social legislation. METHOD: DGAI recommends standardised documentation of parameters representing quality of process (QP) defined by a 63-items list, during every anaesthesia course. Additionally, quality of outcome parameters (QO) defined by a 64-items list should be assessed by an anaesthetist during a standardised postoperative ward round by means of spot checks. A questionnaire covering subjective complaints (SC) and patient satisfaction, is optional. The combination of these tools was evaluated during a 5-month period in every patient (n = 282) on a traumatological surgery ward. RESULTS: QP and QO showed a significant association (p < 0.0001). The incidence of both parameters increases according to risk factors like age and ASA physical status. This was not significant in respect of the type of anaesthesia (p = 0.20). Whereas perioperative QP parameters were less frequent in regional versus general anaesthesia (p < 0.0001), there was no postoperative difference in QO as seen by the anaesthetist (p = 0.20). However, postoperative SC were less frequent with regional anaesthesia (p < 0.0001). The association of QO and SC was mot significant (p = 0.24). There was comparable preoperative morbidity (p = 0.74) for both anaesthetic procedures. 96.5% of all patients expressed overall satisfaction. Despite this fact, nausea (25%), vomiting (29%), thurst (29%) and particularly wound pain (33%) were frequent. CONCLUSIONS: Quality parameters assessed by anaesthetists and patients are independent in respect to their frequency. For this purpose, anaesthesiological quality assurance must focus on both the anaesthetist and the patient. As clinical consequence, we suggest establishing an interdisciplinary post-anaesthesia service. Acceptance by, and collaboration between, the surgical disciplines are indispensable especially for a successful application of effective pain and antiemetic therapy.

[Clinical randomized controlled studies in anesthesiology according to the quality guidelines of good clinical practice. 1: Basic trial design]. / Klinische randomisiert kontrollierte Studien in der Anästhesiologie gemäss den Qualitätsrichtlinien der guten klinischen Praxis. Teil 1: Grundlagen der Planung.

This article was written to give researchers and clinicians a short synopsis of ethical and thorough design, conduct, analysis, publication, and interpretation of randomised controlled clinical trials according to the European quality standards of Good Clinical Practice (GCP). The paper consists of two parts. In the first part we introduce important elements of study design, especially study hypothesis, criteria of inclusion and study population, sample size calculation, validity considerations, bias and confounding, randomisation, stratification, and masking of treatment assignment. Different treatment allocation like multiple parallel groups, factorial experiment, cross-over, and sequential design are presented. Requirements of ethical standards according to the Declaration of Helsinki are discussed for their necessity in any experimentation in humans. Principles of informed consent are demonstrated with emphasis on special conditions in anaesthesia, emergency medicine, and intensive care research. In the second part of this article we explain issues of baseline assessment, experimental intervention, data recording, and data monitoring, particularly of negative or hazardous treatment effects. Topics of data analysis and reporting of trial results in publications are illustrated with regard to their influence on subsequent interpretation.

[Clinical randomized controlled studies in anesthesiology according to quality guidelines of good clinical practice. 2: Principles of implementation, analysis, publication and evaluation]. / Klinische randomisiert kontrollierte Studien in der Anästhesiologie gemäss den Qualitätsrichtlinien der guten klinischen Praxis. Teil 2: Grundlagen der Durchführung, Analyse, Publikation und Bewertung.

This article was written to give researchers and clinicians a short synopsis of ethical and thorough design, conduct, analysis, publication, and interpretation of randomised controlled clinical trials according to the European quality standards of Good Clinical Practice (GCP). The paper consists of two parts. In the first part we introduce important elements of study design, especially study hypothesis, criteria of inclusion and study population, sample size calculation, validity considerations, bias and confounding, randomisation, stratification, and masking of treatment assignment. Different treatment allocation like multiple parallel groups, factorial experiment, cross-over, and sequential design are presented. Requirements of ethical standards according to the Declaration of Helsinki are discussed for their necessity in any experimentation in humans. Principles of informed consent are demonstrated with emphasis on special conditions in anaesthesia, emergency medicine, and intensive care research. In the second part of this article we explain issues of baseline assessment, experimental intervention, data recording, and data monitoring, particularly of negative or hazardous treatment effects. Topics of data analysis and reporting of trial results in publications are illustrated with regard to their influence on subsequent interpretation.

[Incidents, events and complications in the perioperative period in normal and malnurished patients--results of 23,056 patients]. / Zwischenfälle, Ereignisse und Komplikationen in der perioperativen Phase bei normal- und fehlernährten Patienten--Ergebnisse von 23,056 Anästhesien.

AIM: Prevalence of cardiovascular risk factors in anaesthetic patients and perioperative pitfalls, events and complications (PECs) in different nutritional states were examined. The results should contribute to a current project of the German Society of Anaesthesiology and Intensive Care, established for quality assurance. METHOD: Preoperative data (age, sex, defined preexisting diseases, nutritional state, grade of urgency and ASA-class) were integrated in an automatically readable paper record, as well as the perioperative interventions and events, type of anaesthesia, and kind of operation. The records were routinely in use for every patient. After control and correction the data were stored in a modern data base. Data of patients under 16 years of age and incomplete sets of data were excluded from analysis. MAIN RESULTS: From July 1, 1992 to December 31, 1993 23,056 anaesthesias were recorded, 5,852 (25.4%) of them with a total of 8,107 PECs. 17,255 patients had normal body weight and 23% of them PECs. 4,484 obese (but not extremely) patients had a PEC rate of 31.2%, 330 extremely obese patients had a PEC rate of 38.2%, 966 patients with underweight (but not extremely) had a PEC rate of 36.1% and 21 with extreme underweight had a PEC rate of 38.1%. Obese patients had a higher prevalence of preexisting cardiovascular disturbances (angina pectoris, myocardial infarction and hypertension) and tended to a higher incidence of perioperative hypertensive, bronchospastic and hypoxic events as well as more difficulties in application of regional anaesthesia. Young adult patients (16-39 years) had a PEC rate of 14% in case of normal nutritional state but of 20% in case of obesity. The incidence of respiratory PECs and of PECs of higher severity was almost double in obese young patients compared to normal weight patients of the same age. When preoperative cardiovascular disease was known there was little difference between the different states of nutrition in respect of perioperative PECs. CONCLUSIONS: Nutritional disorder is an important epidemiological factor in anaesthesia. Particularly in younger patients without defined preoperative cardiovascular disturbance but with obesity the anaesthesist may be surprised by a remarkable incidence of relevant problems during and immediately after anaesthesia. We should consider the possible phenomenon that we are underestimating the anaesthetic challenge in young obese patients in a "healthy" cardiovascular state.