Der Anaesthesist
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Randomized Controlled Trial
[Preoperative administration of angiotensin-converting enzyme inhibitors].
The discussion about perioperative withdrawal or continuation of angiotensin-converting enzyme inhibitors (ACEI) remains controversial. Should it be continued to avoid peaks in blood pressure and heart rate during anesthesia? Or should it be discontinued the day before to avoid clinically relevant hypotonia? What is the greater risk? Since there are only a few studies dealing with this question, we compared the cardio-circulatory reaction during anesthesia after withdrawal and with continuation of ACEI therapy. ⋯ The continuation of ACEI therapy in the morning is not associated with a better control of blood pressure and heart rate but causes a more pronounced hypotension which forced a therapy more often. Patients chronically treated with ACEI should receive the ACEI the last time on the day before the operation and not with the premedication in the morning.
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Randomized Controlled Trial Comparative Study
[Spinal anaesthesia in day-case surgery. Optimisation of procedures].
Since prilocaine is being increasingly used for day case surgery as a short acting local anaesthetic for spinal anaesthesia and because of its low risk for transient neurological symptoms, we compared it to bupivacaine. ⋯ Under the present study conditions, hyperbaric prilocaine 2% was superior to hyperbaric bupivacaine 0.5% due to a shorter effect profile but otherwise equivalent quality of block. However, puncture in a sitting position and positioning with elevated torso for restriction of the cranial expansion of block spread might cause an enhanced sacral block with delayed recovery of bladder function.
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Randomized Controlled Trial Multicenter Study
[Vasopressin for therapy of persistent traumatic hemorrhagic shock: The VITRIS.at study].
While fluid management is established in controlled hemorrhagic shock, its use in uncontrolled hemorrhagic shock is being controversially discussed, because it may worsen bleeding. In the irreversible phase of hemorrhagic shock that was unresponsive to volume replacement, airway management and catecholamines, vasopressin was beneficial due to an increase in arterial blood pressure, shift of blood away from a subdiaphragmatic bleeding site towards the heart and brain and decrease of fluid resuscitation requirements. The purpose of this multicenter, randomized, controlled, international trial is to assess the effects of vasopressin (10 IU IV) vs. saline placebo IV (up to 3 injections at least 5 min apart) in patients with prehospital traumatic hemorrhagic shock that persists despite standard shock treatment. ⋯ The time window for randomization will close after 30 min of shock treatment. Exclusion criteria are terminal illness, no intravenous access, age <18 years, injury >60 min before randomization, cardiac arrest before randomization, presence of a do-not-resuscitate order, untreated tension pneumothorax, untreated cardiac tamponade, or known pregnancy. Primary study end-point is the hospital admission rate, secondary end-points are hemodynamic variables, fluid resuscitation requirements and hospital discharge rate.
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Randomized Controlled Trial Multicenter Study
[The design of the VISEP trial. Critical appraisal].
The survey transcript of the VISEP interventional trial "Prospective randomized multicenter study on the influence of colloid vs crystalloid volume resuscitation and of intensive vs conventional insulin therapy on outcome in patients with severe sepsis and septic shock" [Clinical trials.gov. identifier: NCT00135473; study start April 2003] comprises, according to the data of the year 2003, methodological shortcomings which challenge a priori the study design and thus the resolution of the purpose of the study, i.e., "determination of the influence of the studied volume and insulin interventions on morbidity and mortality of patients with severe sepsis and septic shock". The most important points of criticism are: 1. A volume therapy with exclusively crystalloids or colloids with the chosen colloid hyperoncotic, hyperchloremic HES solution (10% hydroxyethyl starch: 10% Hemohes) or the crystalloid solution with high lactate content (Sterofundin) is neither acceptable nor practicable, even if only due to exceeding the maximum dosage as recommended by the manufacturer. 2. ⋯ It is doubtful whether an intensified insulin therapy (Actrapid) can be successful if insulin is administered simultaneously with iatrogenic hyperglycemia as a result of lactate influx. Due to these flaws in the design of the VISEP trial, the only consequence can be that the results of the survey are unusable, especially with regard to the point "HES and kidney function". Thus, any further advance presentations and interpretations should be shelved in expectation of the authors' publication of all the data, in order to begin further discussions including the flaws in study design listed here.
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Randomized Controlled Trial
[Dolasetron and shivering. A prospective randomized placebo-controlled pharmaco-economic evaluation].
Forced by the current economical situation, German hospitals have to reconsider their clinical productivity. When caregivers introduce new therapeutic concepts medical quality should either be improved without increasing costs or when reducing costs medical quality should be maintained. In the surgical field postoperative shivering reduces both patient comfort and medical quality. We therefore investigated the clinical pathway prevention of shivering with dolasetron in a prospective, randomized, placebo-controlled analysis of cost-effectiveness. ⋯ The optimization of the clinical process and medical quality induced by a prophylaxis against shivering and postoperative nausea and vomiting compensates for the increased use of pharmaceutical resources in our setting.