It is unclear if avoiding hyperglycemia during intensive care after acute brain injury improves morbidity, mortality, and neurologic outcome. This prospective randomized trial tested whether intensive insulin therapy affected infection rates, vasospasm, mortality, or long-term neurologic outcome in subarachnoid hemorrhage patients during their intensive care unit (ICU) stay. Comparison was made against conventional insulin therapy using a randomized trial design. The primary outcome measure was infection rate until the fourteenth postoperative day in the ICU or until patient discharge. Secondary end points were the incidence of vasospasm until the fourteenth postoperative day in the ICU or until patient discharge, and neurologic outcome and mortality at 6 months follow-up. A total of 78 patients were prospectively enrolled and randomly assigned either to conventional insulin therapy or to intensive insulin therapy (38 and 40 patients, respectively). The infection rate during the study was significantly higher in patients who received conventional insulin therapy than in patients who received intensive insulin therapy (42% vs. 27%; P<0.001). The incidence of vasospasm during the study was also similar in conventional and intensive therapy groups (31.5% vs. 27.6% in the conventional and intensive insulin therapy groups; P=0.9). Overall mortality rates at 6 months were similar in the 2 groups (18% vs.15%; P=0.9), as was the neurologic outcome at 6 months [modified Rankin score >3 in 22/38 patients (57.8%) in the conventional therapy group vs. 21/40 patients (52.5%) in the intensive insulin therapy group; P=0.7]. Intensive insulin therapy in patients with acute subarachnoid hemorrhage admitted to a postoperative neurosurgical ICU after surgical clipping of intracranial aneurysms decreases infection rates. The benefit of strict glycemic control on postoperative vasospasm, neurologic outcome, and mortality rates does not seem to be affected by intensive insulin therapy.
BackgroundPostoperative delirium can result in increased postoperative morbidity and mortality, major demand for postoperative care and higher hospital costs. Hypnotics serve to induce and maintain anaesthesia and to abolish patients' consciousness. Their persisting clinical action can delay postoperative cognitive recovery and favour postoperative delirium. Some evidence suggests that these unwanted effects vary according to each hypnotic's specific pharmacodynamic and pharmacokinetic characteristics and its interaction with the individual patient.We designed this study to evaluate postoperative delirium rate after general anaesthesia with various hypnotics in patients undergoing surgical procedures other than cardiac or brain surgery. We also aimed to test whether delayed postoperative cognitive recovery increases the risk of postoperative delirium.Methods/DesignAfter local ethics committee approval, enrolled patients will be randomly assigned to one of three treatment groups. In all patients anaesthesia will be induced with propofol and fentanyl, and maintained with the anaesthetics desflurane, or sevoflurane, or propofol and the analgesic opioid fentanyl.The onset of postoperative delirium will be monitored with the Nursing Delirium Scale every three hours up to 72 hours post anaesthesia. Cognitive function will be evaluated with two cognitive test batteries (the Short Memory Orientation Memory Concentration Test and the Rancho Los Amigos Scale) preoperatively, at baseline, and postoperatively at 20, 40 and 60 min after extubation.Statistical analysis will investigate differences in the hypnotics used to maintain anaesthesia and the odds ratios for postoperative delirium, the relation of early postoperative cognitive recovery and postoperative delirium rate. A subgroup analysis will be used to categorize patients according to demographic variables relevant to the risk of postoperative delirium (age, sex, body weight) and to the preoperative score index for delirium.DiscussionThe results of this comparative anaesthesiological trial should whether each the three hypnotics tested is related to a significantly different postoperative delirium rate. This information could ultimately allow us to select the most appropriate hypnotic to maintain anaesthesia for specific subgroups of patients and especially for those at high risk of postoperative delirium.Registered at Trial.gov NumberClinicalTrials.gov: NCT00507195
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