F1000Research
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Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18 th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. ⋯ The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area.
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Background: Obesity, abdominal surgery, and intrathecal opioids are all factors associated with a risk for respiratory compromise. The aim of this explorative trial was to study the apnoea/hypopnea index 1st postoperative night in obese mothers having had caesarean section (CS) in spinal anaesthesia with a combination of bupivacaine/morphine and fentanyl. Methods: Consecutive obese (BMI >30 kg/m 2) mothers, ≥18 years, scheduled for CS with bupivacaine/morphine/fentanyl spinal anaesthesia were monitored with a portable polygraphy device Embletta /NOX on 1 st postoperative night. ⋯ Conclusion: Respiratory polygraphy 1 st night after caesarean section in spinal anaesthesia with morphine in moderately obese mothers showed AHIs that in sleep medicine terms are considered normal, mild and moderate. Obstructive events and episodes of desaturation were commonly not synchronised. Further studies looking at preoperative screening for sleep apnoea in obese mothers are warranted but early postop respiratory polygraphy recording is cumbersome and provided sparse important information.
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Rho GTPases are crucial signaling molecules that regulate a plethora of biological functions. Traditional biochemical, cell biological, and genetic approaches have founded the basis of Rho GTPase biology. The development of biosensors then allowed measuring Rho GTPase activity with unprecedented spatio-temporal resolution. ⋯ In this review, we describe Rho GTPase activity patterns observed in different cell systems. We then discuss the growing body of evidence that upstream regulators such as guanine nucleotide exchange factors and GTPase-activating proteins shape these patterns by precisely controlling the spatio-temporal flux of Rho GTPase activity. Finally, we comment on additional mechanisms that might feed into the regulation of these signaling patterns and on novel technologies required to dissect this spatio-temporal complexity.
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Upper extremity blocks are useful as both sole anaesthesia and/or a supplement to general anaesthesia and they further provide effective postoperative analgesia, reducing the need for opioid analgesics. There is without doubt a renewed interest among anaesthesiologists in the interscalene, supraclavicular, infraclavicular, and axillary plexus blocks with the increasing use of ultrasound guidance. The ultrasound-guided technique visualising the needle tip and solution injected reduces the risk of side effects, accidental intravascular injection, and possibly also trauma to surrounding tissues. ⋯ The use of perineural catheters is an effective option to improve and prolong the postoperative analgesic effect. Upper extremity plexus blocks have an obvious place as a sole anaesthetic technique or as a powerful complement to general anaesthesia, reducing the need for analgesics and hypnotics intraoperatively, and provide effective early postoperative pain relief. Continuous perineural infusion is an effective option to prolong the effects and improve postoperative quality.
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Regional anaesthesia provides effective anaesthesia and analgesia in the perioperative setting. Central neuraxial blocks-that is, spinal and epidural blocks-are well established as an alternative or adjunct to general anaesthesia. Peripheral blocks may be used as part of multimodal anaesthesia/analgesia in perioperative practice, reducing the need for opioid analgesics and enhancing early recovery. ⋯ This article provides an overview of current evidence around quality of recovery, risk for delirium, long-term effects, and possible impact on cancer disease progression associated with the clinical use of local and regional anaesthetic techniques. In summary, there is still a lack of robust data that regional anaesthesia has a clinical impact beyond its well-acknowledged beneficial effects of reducing pain, reduced opioid consumption, and improved quality of early recovery. Further high-quality prospective studies on long-term outcomes are warranted.