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Randomized Controlled Trial Comparative Study
A comparison of the effect of high- and low-dose fentanyl on the incidence of postoperative cognitive dysfunction after coronary artery bypass surgery in the elderly.
Postoperative cognitive dysfunction (POCD) after coronary artery bypass graft surgery is a common complication for which, despite many clinical investigations, no definitive etiology has been found. The current use of both high- and low-dose fentanyl as anesthetic techniques allowed us to investigate the effect of fentanyl on the incidence of POCD. ⋯ High-dose fentanyl is not associated with a difference in the incidence of POCD at 3 or 12 months after surgery. Low-dose fentanyl leads to shorter postoperative ventilation times and may be associated with a greater incidence of POCD 1 week after surgery. Early POCD is associated with an increased duration of stay in the hospital.
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Randomized Controlled Trial Multicenter Study Comparative Study
Assessment of jugular endovascular malformations in chronic cerebrospinal venous insufficiency: colour-Doppler scanning and catheter venography compared with intravascular ultrasound.
Chronic cerebrospinal venous insufficiency (CCSVI) is a malformative condition characterized by several anomalies of the azygos and/or internal jugular veins (IJVs). Recommended diagnosis of CCSVI is performed with colour-Doppler (CD) sonography. Though catheter venography (CV) is considered as the gold standard for determining vascular anatomy, its uniplanar point of view does not allow an overall evaluation of endoluminal structures. This limit could be addressed by intravascular ultrasound (IVUS). The aim of this report is to evaluate, in patients with multiple sclerosis (MS), the accuracy of CD sonography and CV versus IVUS in estimating the diameter and the cross-sectional area (CSA) of the IJVs and in detecting jugular endoluminal malformations (JEM). ⋯ CV was significantly inferior to CD sonography and IVUS in detecting JEM. Differences between IVUS and CD sonography in detecting JEM and in quantifying jugular diameters were not significant. The IJV CSA was underestimated by CD sonography compared with IVUS. CD sonography was proven to be important in the anatomical characterization of CCSVI, providing useful information for correct intravascular treatment.
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Randomized Controlled Trial
Reduced morphine consumption and pain intensity with local infiltration analgesia (LIA) following total knee arthroplasty.
Postoperative pain is often severe after total knee arthroplasty (TKA). We investigated the efficacy of the local infiltration analgesia (LIA) technique, both intraoperatively and postoperatively. ⋯ The local infiltration analgesia (LIA) technique provides excellent pain relief and lower morphine consumption following TKA, resulting in shorter time to home readiness and higher patient satisfaction. There were few side effects and systemic LA concentrations were low.
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Randomized Controlled Trial Multicenter Study
HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial.
Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. ⋯ Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT.
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Randomized Controlled Trial Multicenter Study
GREAT-a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment.
The effectiveness of a hybrid hydrogel platinum detachable coil (HydroCoil; MicroVention Inc., Tustin, CA) for endovascular aneurysm treatment has been proven in a recently published RCT. Due to technical restrictions (coil stiffness, time restriction for placement), the HydroSoft coil as well as a corresponding 3D framing coil, the HydroFrame coil (MicroVention Inc., Tustin, CA), a class of new softer coils containing less hydrogel and swelling more slowly than the HydroCoil, have been developed and brought to clinical practice. The present study aims to compare the effectiveness of endovascular aneurysm treatment with coil embolization between patients allocated HydroSoft/HydroFrame versus bare platinum coiling. ⋯ Exclusion criteria were as follows: aneurysms previously treated by coiling or clipping. Primary endpoint is a composite of major aneurysm recurrence on follow-up angiography and poor clinical outcome (modified Rankin scale 3 or higher), both assessed at 18 months post treatment. Risk differences for poor outcomes will be estimated in a modified intention-to-treat analysis stratified by rupture status (DRKS-ID: DRKS00003132).