BMJ open
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Randomized Controlled Trial
Impact of dexmedetomidine infusion during general anaesthesia on incidence of postoperative delirium in elderly patients after major non-cardiac surgery: study protocol of a randomised, double-blinded and placebo-controlled trial.
Delirium is a common complication in the elderly after surgery and is associated with worse outcomes. Multiple risk factors are related with postoperative delirium, such as exposure to general anaesthetics, pain and postoperative inflammatory response. Preclinical and clinical studies have shown that dexmedetomidine attenuated neurotoxicity induced by general anaesthetics, improved postoperative analgesia and inhibited inflammatory response after surgery. Several studies found that intraoperative use of dexmedetomidine can prevent postoperative delirium, but data were inconsistent. This study was designed to investigate the impact of dexmedetomidine administered during general anaesthesia in preventing delirium in the elderly after major non-cardiac surgery. ⋯ The study protocol was approved by the Clinical Research Ethics Committee of Peking University First Hospital (2015-987) and registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn) with identifier ChiCTR-IPR-15007654. The results of the study will be presented at academic conferences and submitted to peer-reviewed journals.
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Randomized Controlled Trial
Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.
As opioid analgesic consumption has grown, so have opioid use disorder and opioid-related overdoses. Reducing the quantity of opioid analgesics prescribed for acute non-cancer pain can potentially reduce risks to the individual receiving the prescription and to others who might unintentionally or intentionally consume any leftover tablets. Reducing the default dispense quantity for new opioid analgesic prescriptions in the electronic health record (EHR) is a promising intervention to reduce prescribing. ⋯ This study has been approved by the Montefiore Medical Center/Albert Einstein College of Medicine Institutional Review Board with a waiver of informed consent (2016-6036) and is registered on ClinicalTrials.gov (NCT03003832, 6 December 2016). Findings will be disseminated through publication, conferences and meetings with health system leaders.
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Randomized Controlled Trial
Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS): protocol for a randomised, double-blind, parallel-arm, placebo-controlled trial.
Delirium, which is prevalent in postcardiac surgical patients, is an acute brain dysfunction characterised by disturbances in attention, awareness and cognition not explained by a pre-existing neurocognitive disorder. The pathophysiology of delirium remains poorly understood. However, basic science and clinical studies suggest that sleep disturbance may be a modifiable risk factor for the development of delirium. Dexmedetomidine is a α-2A adrenergic receptor agonist medication that patterns the activity of various arousal nuclei similar to sleep. A single night-time loading dose of dexmedetomidine promotes non-rapid eye movement sleep stages N2 and N3 sleep. This trial hypothesises dexmedetomidine-induced sleep as pre-emptive therapy for postoperative delirium. ⋯ The Partners Human Research Committee approved the MINDDS trial. Recruitment began in March 2017. Dissemination plans include presentations at scientific conferences, scientific publications and popular media.
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Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical Trial
Intermittent versus continuous oxygen saturation monitoring for infants hospitalised with bronchiolitis: study protocol for a pragmatic randomised controlled trial.
Bronchiolitis is the most common reason for hospitalisation in infants in developed countries. The main focus of hospital care is on supportive care, such as monitoring for hypoxia and supplemental oxygen administration, as active therapies lack effectiveness. Pulse oximetry is used to monitor hypoxia in hospitalised infants and is used either intermittently or continuously. Observational studies have suggested that continuous pulse oximetry use leads to a longer length of hospital stay in stable infants. The use of continuous pulse oximetry may lead to unnecessary clinical intervention due to readings that are of little clinical significance, false-positive readings and less reliance on the clinical status. There is a lack of high-quality evidence to guide which pulse oximetry monitoring strategy, intermittent or continuous, is superior in infants hospitalised with bronchiolitis with respect to patient and policy-relevant outcomes. ⋯ Research ethics approval has been obtained for this trial. This trial will provide data to guide hospitals and clinicians on the optimal pulse oximetry monitoring strategy in infants hospitalised with bronchiolitis. We will disseminate the findings of this study through peer-reviewed publication, professional societies and meetings.
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Randomized Controlled Trial Comparative Study
Protocol for a phase III, non-inferiority, randomised comparison of a new fibrinogen concentrate versus cryoprecipitate for treating acquired hypofibrinogenaemia in bleeding cardiac surgical patients: the FIBRES trial.
Coagulopathic bleeding is a serious complication of cardiac surgery to which an important contributor is acquired hypofibrinogenaemia (plasma fibrinogen <1.5-2.0 g/L). The standard intervention for acquired hypofibrinogenaemia is cryoprecipitate, but purified fibrinogen concentrates are also available. There is little comparative data between the two therapies and randomised trials are needed. ⋯ The study is approved by the local research ethics board and will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. Patient consent prior to treatment is waived, as per criteria in the Tri-Council Policy Statement. Results will be published in the scientific/medical literature, and at international congresses. Non-inferiority of purified fibrinogen concentrate would support its use in acquired hypofibrinogenaemia. The results are likely to improve care for cardiac surgical patients experiencing significant bleeding, an understudied yet high-risk population.