A Study Protocol published in Trials aims to investigate the impact of intravenous dexamethasone on sleep quality and duration of patients undergoing robot-assisted radical prostatectomy.
) of surgery, and 30 min after awakening . The following parameters will be recorded: operative time, anesthesia time, intraoperative blood loss, intraoperative fluid volume, intraoperative dosage of sufentanil and remifentanil, type and dosage of intraoperative vasoactive drug, wake time , and VAS score for resting and coughing 30 min after awakening. All patients will be followed up by a designated person within 72 h after operation.
Data analysis will be conveyed to an independent Data Monitoring Committee with utmost confidentiality, wherein this committee will be tasked with evaluating the cumulative trial data and other pertinent research findings to ascertain the justifiability of recruiting additional participants. It is within their purview to offer suggestions in this regard.
Regulatory officials convene monthly meetings to review the conduct of the trial. In accordance with the specific risk assessment of the trial and the documentation in the monitoring plan, on-site monitoring will be conducted. Supervisors will be granted authorization to conduct trial-related monitoring, regulatory inspections, audits, and ethical reviews, while also being provided with direct access to source data/documents.
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Common mental health disorders in adults with inflammatory skin conditions: nationwide population-based matched cohort studies in the UK - BMC MedicineBackground Psoriasis and atopic eczema are common inflammatory skin diseases. Existing research has identified increased risks of common mental disorders (anxiety, depression) in people with eczema and psoriasis; however, explanations for the associations remain unclear. We aimed to establish the risk factors for mental illness in those with eczema or psoriasis and identify the population groups most at risk. Methods We used routinely collected data from the UK Clinical Practice Research Datalink (CPRD) GOLD. Adults registered with a general practice in CPRD (1997–2019) were eligible for inclusion. Individuals with eczema/psoriasis were matched (age, sex, practice) to up to five adults without eczema/psoriasis. We used Cox regression to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for hazards of anxiety or depression in people with eczema/psoriasis compared to people without. We adjusted for known confounders (deprivation, asthma [eczema], psoriatic arthritis [psoriasis], Charlson comorbidity index, calendar period) and potential mediators (harmful alcohol use, body mass index [BMI], smoking status, and, in eczema only, sleep quality [insomnia diagnoses, specific sleep problem medications] and high-dose oral glucocorticoids). Results We identified two cohorts with and without eczema (1,032,782, matched to 4,990,125 without), and with and without psoriasis (366,884, matched to 1,834,330 without). Sleep quality was imbalanced in the eczema cohorts, twice as many people with eczema had evidence of poor sleep at baseline than those without eczema, including over 20% of those with severe eczema. After adjusting for potential confounders and mediators, eczema and psoriasis were associated with anxiety (adjusted HR [95% CI]: eczema 1.14 [1.13–1.16], psoriasis 1.17 [1.15–1.19]) and depression (adjusted HR [95% CI]: eczema 1.11 [1.1–1.12], psoriasis 1.21 [1.19–1.22]). However, we found evidence that these increased hazards are unlikely to be constant over
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