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  • 1
    ISSN: 1432-055X
    Keywords: Schlüsselwörter Prospektive Studie ; Neurolept- ; balancierte- ; Propofolanästhesie ; Qualitätskontrolle ; Intraoperative Komplikationen (ZEK) ; Vigilanz ; Patientenzufriedenheit ; Key words Anaesthesia ; Comparative ; randomised study ; Neurolept- ; balanced ; and intravenous propofol anaesthesia ; Quality assurance ; Intraoperative complications (IEC) ; Vigilance ; Patient satisfaction
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract The safety and tolerance of neuroleptanaesthesia (NLA), balanced anaesthesia (BAL), and intravenous anaesthesia with propofol (IVA) were analysed for the first time in a prospective, randomised clinical trial. Methods. In all, 1318 surgical patients received either NLA, BAL, or IVA. Patients who had regional anaesthesia, were aged under 18 years, or were nonco-operative or vitally threatened (ASA class IV to V) did not participate in the study. Premedication and anaesthetic course were set up at a standard of 30% oxygen and 70% nitrous oxide. Incidents, events, and complications due to anaesthesia were obtained (IEC key of the German Society of Anaesthesia and Critical Care Medicine, DGAI). Furthermore, postanaesthetic alertness based on specific recovery tests and the quality of anaesthesia from the patient's viewpoint, rated by patient questionnaires from the DGAI were evaluated. All parameters were calculated and checked for statistical significance using the chi-square test. Results and discussion. The groups were broadly comparable with respect to age (P=0.91), ASA class (P=0.42), preoperative blood pressure (P=0.36), and length of anaesthesia (P=0.82). The anaesthesia, which averaged 103 min, comprised the following regimens: (1) NLA: 7.1 mg droperidol and 0.008 mg/kg body weight fentanyl, (2) IVA: 493.4 mg propofol and 0.004 mg/kg body weight fentanyl, and (3) BAL: 2.6 mg droperidol and 0.004 mg/kg body weight fentanyl with 0.4 vol.% isoflurane. With respect to anaesthetic risk, the following reactions were observed: the use of NLA led to a high incidence of tachycardia (P=0.001), arrhythmias (P=0.05), and hypertensive reactions (P= 0.001), whereas in the IVA group only hypotension (P=0.0001) occurred. However, after the use of BAL none of the aforementioned complications were detectable to any considerable degree. Similarly, patients who had cardiac disease showed greater IEC changes after the use of NLA than after BAL or IVA (P=0.02) (Tables 1 and 2). The heart rates and blood pressures during BAL and IVA were extremely stable, and therefore, vasoactive therapy was required considerably less in comparison to NLA (P=0.001) (Table 4). Recovery after the use of IVA was strikingly rapid: the patient's responsiveness, orientation, and ability to concentrate was significantly better than after the other anaesthetic regimen (P=0.01) (Table 5). With regard to the typical discomforts after anaesthesia, IVA was highly superior to BAL and NLA: nausea (P=0.0003) and retching (P=0.03) hardly ever occurred (Table 6). Due to the tolerable manner of waking up and rapid return of orientation and the ability to concentrate, IVA was highly favoured by the patients (P=〈0.01) (Table 7). Conclusion. The present results show clear clinical advantages of BAL and IVA in contrast to neuroleptanaesthesia. Due to the very low incidence of side effects such as nausea and vomiting IVA was highly recommended by the patients, at least in part because of the rapid recovery time.
    Notes: Zusammenfassung Bei 1318 Patienten wurden Narkosesicherheit, Verträglichkeit und Vigilanz nach Neurolept – (NLA), balancierter – (BAL) – und intravenöser Propofolanästhesie (IVA) anhand von DGAI-ZEKListe und -Fragebogen sowie spezieller Vigilanztests analysiert. Prämedikation und Narkoseführung waren standardisiert. Als Ausdruck unterschiedlicher Narkosesicherheit wurden nach NLA bei 45%, nach BAL und IVA bei 35% bzw. 36% der Patienten therapiebedürftige Ereignisse registriert (p=0,004). Im einzelnen zeigten NLA-Patienten gehäuft Tachykardien, Arrhythmien und Hypertonien (p=0,05), während bei IVA Hypotensionen vermehrt beobachtet wurden (p〈0,001). Schwere kardiohämodynamische Ereignisse waren bei lediglich 6,6% aller Patienten zu verzeichnen, wobei 5% der IVA-Patienten im Vergleich zu 6,3% bzw. 8,3% nach BAL und NLA intensivtherapiepflichtige Interventionen am seltensten nötig hatten. Hinsichtlich ihrer Ansprechbarkeit, Konzentrations- und Sprachfähigkeit wurden IVA- und NLA-Patienten ungleich besser bewertet als die verzögert erwachenden BAL-Patienten (p〈0,05). Da zudem Übelkeit und Erbrechen nach IVA signifikant geringer ausgeprägt waren (p〈0,05), wurde diese Narkose aus Patientensicht hoch favorisiert (p〈0,01). Insgesamt ging daher die IVA aufgrund der geringen Zahl gravierender kardiohämodynamischer Komplikationen (ZEK), einer kurzen Aufwachphase und fehlender Nebenwirkungen als das beste Verfahren aus diesem Vergleich hervor.
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  • 2
    ISSN: 1432-055X
    Keywords: Schlüsselwörter Prospektive Studie ; Neurolept- ; balancierte- ; Propofolanästhesie ; Qualitätskontrolle ; Studiendesign ; Patientenkollektive ; Ergebniskriterien ; Kostenanalyse ; Key words General anaesthesia ; Comparative ; randomised study ; Neurolept- ; balanced ; and intravenous propofol anaesthesia ; Quality assurance ; Study design ; Demographics ; Outcome criteria ; Cost analysis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract The choice of appropriate anaesthesia in a more or less seriously ill patient requires detailed information on the risk and tolerance of each specific anaesthetic regimen. The objective of this prospective, randomised clinical trial was to test the hypothesis that three regimens of general anaesthesia – neurolept-(NLA), balanced (BAL), and intravenous propofol anaesthesia (IVA) - differ with regard to safety and comfort. The criteria for the intraoperative safety and postoperative comfort of the patients were the incidents, events and complications (IEC) that required medical treatment as well as the evaluation of postoperative complaints by the patients according to the IEC list and patient questionnaires of the German Society of Anaesthesia and Critical Care Medicine (DGAI). Methods. The study duration was about 4 months, from January to April 1992. During this period the patients of all nine operative departments of the hospital received strictly randomised NLA, BAL, or IVA. Patients who had regional anaesthesia or were not capable of understanding the German language, were nonco-operative, or were seriously ill (ASA class IV to V) as well as children under 18 years of age did not participate in the study. All eligible patients provided their informed consent. Anaesthesia. For premedication 10 mg chlorazepate was administered the night before and on the day of surgery. Anaesthesia was conducted under normoventilation using a mixture of 70% nitrous oxide and 30% oxygen. NLA patients were induced intravenously with 0.2 mg/kg body weight etomidate and received 0.005 mg/kg fentanyl and 0.07 mg/kg droperidol before the start of surgery. The repetition dose was 0.2 mg fentanyl and 2.5 mg droperidol. In the BAL patients the dose of fentanyl and droperidol was reduced to 50% due to the addition of isoflurane up to 1 vol. %. IVA patients received 2 mg/kg propofol over 3 min followed by an infusion of 3–5 mg/kg per hour together with 0.2 mg fentanyl/h. Neuromuscular blockade was accomplished with vecuronium 0.1 mg/kg. If the blood pressure and heart rate increased by more than 20% of preoperative values, analgesia was reinforced by an additional fentanyl dose. Anaesthesia was subsequently enhanced by increasing the neurolept/propofol/isoflurane dose by up to 50%. Data collection. The following parameters were registered: patients' personal data and physical condition according to ASA classification; the grade of risk according to the Munich risk checklist; the frequency of IEC during surgery; the patients' permanent medications; postanaesthetic vigilance and recovery; the acceptance of the assigned anaesthetic by the physician; the cost of the anaesthetic used; and pre- and postoperative complaints as well as the assessment of anaesthesia by the patient. The statistical evaluation was performed using the chi-square test. Results. A total of 1,346 patients were enrolled in the study; 28 (2%) were excluded because the treatment protocol was changed by the anaesthesiologist. Seventy per cent were recruited from general, gynaecologic, or otorhinolaryngologic surgery. The three anaesthetic regimens (NLA, BAL, and IVA) were used in other departments with the same frequency with the exception of ophthalmology and urology (P〉0.1) (Fig. 1). Of the 1,318 eligible patients, 443 received NLA, 443 BAL, and 432 IVA (P=0.8). The distribution of the various parameters was surprisingly similar among the three groups: the average age was 50 years (P=0.91), body weight 71 kg (P=0.33), reference or initial blood pressure 130/80 mm Hg (P=0.36), average time of anaesthesia 103 min (P=0.82), and all had the same risk score (P=0.42). Sixty per cent were female. An average of 85% of the 18- to 89-year-old patients were considered to be healthy according to the ASA risk classification (P=0.42). However, on applying the Munich risk checklist the average number of healthy individuals was 5% to 10% lower than that of the ASA risk classification. The average quantity of anaesthetics per patient in the NLA group was 7.1 mg droperidol and 0.54 mg fentanyl; in the BAL group the amount could be reduced to 50% by adding isoflurane, and in the IVA group propofol 493 mg/100 min was given with 0.3 mg fentanyl (Fig. 2). The costs of the three regimens were 27.43 DM for NLA, 31.68 DM for BAL, and 43.75 DM for IVA. Conclusion. The remarkably high degree of consistency of the patients' baseline characteristics as well as the equal distribution among the patient groups can be considered optimal randomisation. The present clinical trial compared the safety and tolerance of the three anaesthetic regimens under routine daily conditions. The results of the study should have great clinical significance for the choice of the appropriate anaesthetic regimen while considering safety, tolerance, and cost-benefit aspects.
    Notes: Zusammenfassung Zielkriterien des Qualitätsvergleichs von Neurolept- (NLA), balancierter- (BAL)- und intravenöser (IVA) Anästhesie waren Narkosesicherheit und Patientenwohlbefinden. Anhand des Zwischenfall-, Ereignis- und Komplikationsschlüssels (ZEK) der Deutschen Gesellschaft für Anästhesiologie und Intensivmedizin (DGAI) wurde ein seltener ZEK-Eintritt als Ausdruck einer hohen Narkosesicherheit gewertet. Die Analyse des Patientenwohlbefindens erfolgte mit Hilfe des DGAI-Patientenfragebogens. Von 1346 Patienten absolvierten 1318 das Studienprotokoll ordnungsgemäß. Bei 28 Patienten (2%) wurde das vorgegebene Verfahren vom Narkosearzt nicht akzeptiert, so daß deren Daten keine Berücksichtigung fanden. Die Patienten rekrutierten aus 9 Fachbereichen. Das Durchschnittsalter lag bei 50 Jahren (p=0,91), das durchschnittliche Körpergewicht betrug 71 kg (p=0,33). Der präoperative Referenzblutdruck erreichte im Mittel eine Höhe von 131/79 mmHG (p=0,36). 85% der Patienten wurden in die Kategorie ASA I und II eingestuft (p=0,42). Einen vergleichbaren Anteil gesunder Patienten ergab die Risikoeinschätzung nach der Münchener Risikocheckliste (p=0,16). Im Rahmen der postoperativen Patientenbefragung wurden 799 (60%) auswertbare Fragebögen zurückgesandt. Die Zahl der antwortenden Patienten war mit 263, 265 und 271 je Gruppe nahezu gleich (p=0,91) und unterschied sich nicht hinsichtlich Alter (p= 0,97), Geschlecht (p=0,8), Risikoschweregrad (p=0,68) und Narkosedauer (p=0,95). Die hohe Übereinstimmung der Basisdaten war die Voraussetzung zur Objektivierung verfahrensspezifischer Unterschiede.
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  • 3
    ISSN: 1432-0711
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
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