Protocol to evaluate the feasibility of the D-PRESCRIBE intervention adapted to the Belgian community setting (END-IT CS study)

Introduction
Benzodiazepine receptor agonists (BZRA) deprescribing interventions are needed to tackle high BZRA use in the older population. This study aims to assess the feasibility of the D-PRESCRIBE intervention, adapted from Canada to the Belgian community setting. This pharmacist-led intervention comprises a patient educational brochure and a pharmacist-to-prescriber communication tool.

Methods and analysis
We will conduct a feasibility study of a cluster randomised controlled trial involving 8–10 community pharmacies (clusters) and aiming to recruit 56–80 patients (≥65 years). Intervention pharmacies will deliver the adapted D-PRESCRIBE intervention and control pharmacies, usual care. Patients will be blinded to group allocation. Quantitative data will be collected at baseline, 3 months and 6 months through patients’ and pharmacists’ questionnaires, aiming: (1) to test the feasibility of the intervention, (2) to test the feasibility of the study design needed for its evaluation and (3) to perform an exploratory cost-effectiveness analysis. Hence, data about implementation outcomes, mechanisms of impact (ie, mechanisms through which the intervention is supposed to be effective) and contextual factors will be gathered. Patient-centred outcomes will also be collected as they would be in a full cost-effectiveness trial. The feasibility of the study design will be assessed through participation rate, completeness of the data and a satisfaction survey, sent to participants after the 6-month data collection. Data will be analysed using descriptive statistics. To gain a deeper understanding of pharmacists and patients’ experience with the intervention, interviews will be conducted after the 6-month data collection and the Theoretical Domains Framework will be used as a deductive framework for analysis.

Ethics and dissemination
This study was approved by the Ethics Committee of CHU UCL Namur (NUB: B0392023000036). Participants will receive a summary of the results. Results will also be disseminated through the organisation of a local symposium and a peer-reviewed publication.

Trial registration number
NCT05929417.

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Comparison of remimazolam-based and propofol-based general anaesthesia on postoperative quality of recovery in patients undergoing laparoscopic sleeve gastrectomy: protocol for a prospective, randomised, parallel-group, non-inferiority trial

Introduction
Remimazolam is a novel short-acting benzodiazepine that exhibits sedative and hypnotic properties without compromising respiratory function and while maintaining haemodynamic stability. Its safety and efficacy have been demonstrated to be non-inferior to those of propofol in the context of general anaesthesia. Nevertheless, the non-inferiority in terms of postoperative recovery quality in obese patients has not been established. Thus, we conducted a prospective, randomised, parallel-group, non-inferiority study to compare remimazolam-based general anaesthesia with propofol-based general anaesthesia on the postoperative quality of recovery (QoR) in patients undergoing laparoscopic sleeve gastrectomy.

Methods and analysis
All participants meeting the included criteria will be enrolled after signing an informed consent form. Patients will be randomly allocated to either the propofol group (n=63; induction and maintenance with propofol) or the remimazolam group (n=63; induction and maintenance with remimazolam). The primary endpoint of the study is the 15-item QoR Scale assessed at 24 hours postoperatively. Secondary endpoints include the doses of anaesthetic required for loss of consciousness (LOC), the time to LOC, the time to recovery of consciousness, the total amount of anaesthetic administered during the surgery and the incidence of hypotension and bradycardia. Additionally, postoperative profiles of pain, nausea and vomiting, delirium, intraoperative awareness, adverse events and patient satisfaction will be collected. Statistical analyses will be performed using IBM SPSS Statistics V.26.0 and GraphPad Prism V.5.01. Statistical significance is set at two-sided p values

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Safety and efficacy of remimazolam in mechanical ventilation in the ICU: a protocol for systematic evaluation and meta-analysis

Introduction
Remimazolam is a novel ultra-short-acting benzodiazepine that allosterically modulates -aminobutyric acid type A receptors to induce sedative effects. Remimazolam was approved by China for procedural sedation in 2020. Intensive care unit (ICU) patients frequently exhibit impaired liver and renal function as well as haemodynamic instability; thus, the pharmacokinetic properties of remimazolam may offer advantages for ICU sedation. A comprehensive evaluation of the relevant studies warrants further discussion. This systematic review aims to compare the efficacy and safety of the novel intravenous anaesthetic remimazolam with that of commonly used anaesthetics in the ICU.

Methods and analysis
The following databases will be searched: Embase, Cochrane Library, PubMed, MEDLINE, Web of Science, CNKI and WanFang to retrieve relevant randomised controlled trials (RCTs). This protocol was developed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols 2020. RCTs about the use of remimazolam for sedation during ICU mechanical ventilation will be included. Two investigators will independently screen articles and extract data according to predefined inclusion and exclusion criteria. Following a qualitative evaluation of each study, data analysis will be conducted using Review Manager 5.4 software. The planned start and end dates for the study were placed on 1 June 2024 and 31 October 2024, respectively.

Ethics and dissemination
This protocol for the systematic evaluation and meta-analysis does not involve individual patient data; thus, ethical approval is not required. This will be the first meta-analysis to assess the sedative efficacy and safety of remimazolam in the ICU and to provide evidence to inform clinical decision-making. The findings will be disseminated through conference presentations and publications in peer-reviewed journals relevant to the field.

PROSPERO registration number
CRD42024554425

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Efficacy and safety of remimazolam tosylate for patients undergoing off-pump coronary artery bypass grafting: a study protocol for a non-inferiority randomised controlled trial in China

Introduction
Maintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel ultra-short-acting benzodiazepine with minimal cardiovascular depression. Currently, non-inferior studies comparing the haemodynamic changes induced by remimazolam and etomidate are limited. This study aims to assess the efficacy and safety of remimazolam tosylate for the induction and maintenance of GA in patients undergoing OPCABG.

Method and analysis
This two-armed non-inferiority randomised controlled trial will include 88 patients aged 18–75 years who are scheduled for OPCABG. Patients will be randomly assigned in a 1:1 ratio to receive either remimazolam tosylate or etomidate and propofol for anaesthesia induction and maintenance. The primary outcome will be the fluctuation of mean artery pressure during anaesthesia induction. Secondary outcomes will include adverse events, adverse drug reactions, the cumulative dosage of vasoactive drugs, vital signs and bispectral index values at different time points, lengths of postoperative mechanical ventilation and tracheal intubation, lengths of intensive care unit stay and hospital stay and hospital mortality. Analyses will be conducted using both the intention-to-treat approach and the per-protocol approach.

Ethics and dissemination
This study was approved by the Ethics Committee of Zibo Central Hospital (No. 2024001). The trial results will be submitted to an international peer-reviewed journal.

Trial registration number
ChiCTR.gov.cn: ChiCTR2400079615.

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Abstract 4140180: The Effect of Benzodiazepine Use in Patients with Atrial Fibrillation and Obstructive Sleep Apnea

Circulation, Volume 150, Issue Suppl_1, Page A4140180-A4140180, November 12, 2024. Introduction:Sleep apnea is a common sleep disorder that can worsen atrial fibrillation(AF) prognosis. Benzodiazepines(BZD) are commonly prescribed for insomnia, which often accompanies sleep apnea. However, BZDs have been associated with worsening of sleep apnea due to respiratory depression, pharyngeal muscle relaxation, and increase of arousal threshold, which all may lead to prolonged hypoxia. There is little research on the effect of BZD use in AF patients with sleep apnea. Therefore, the objective of this study is to investigate the effects of BZD usage on outcomes in the AF population with sleep apnea.Methods:Data from patients with AF and sleep apnea seen at Tulane Medical Center between 2010 and 2019 was obtained from Research Action for Health Network(REACHnet), a Clinical Research Network in PCORnet®. Patients with AF and sleep apnea were divided between those with a prescription of BZD and those without BZD. These two groups were compared using the Kaplan-Meier method for time-to outcome for all-cause mortality, ischemic stroke, myocardial infarction(MI), and hospitalizations in the five years following their AF diagnosis. Cox regression analysis was used to investigate proportional hazards and control for demographics, comorbidities, and medication use.Results:There were 524 total patients included with AF and sleep apnea. Of these, 413(78.8%) were not prescribed BZDs, while 111(21.1%) were taking BZDs. Use of BZDs was associated with worse outcomes. In the no BZD and the BZD group over the 5 years following AF diagnosis, the rate of mortality was 6.1% and 12.6%(p

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Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial

Introduction
Despite several calls to deprescribe benzodiazepine receptor agonists (BZRA) in older adults, their use among nursing home residents (NHRs) remains high. Therefore, we developed an intervention targeting general practitioners’ and healthcare professionals’ behaviours regarding BZRA deprescribing in nursing homes (NHs): The END-IT NH (bENzodiazepines Deprescribing InTerventions Nursing homes) 6-component intervention. Before moving on to a large-scale effectiveness and cost-effectiveness evaluation, this feasibility study aims at: (1) assessing the feasibility of the intervention implementation in NHs, (2) assessing the feasibility of conducting a larger-scale evaluation, in terms of recruitment and data collection and (3) conducting an exploratory cost-effectiveness evaluation.

Methods and analysis
We will conduct a cluster-randomised controlled trial in a sample of 6 NHs, with 10–15 NHRs included per NHs. Four NHs will be randomised into the intervention group, and two NHs will deliver usual care (control group). Data collection will occur at baseline, 3, and 6 months (study end). We will collect information to explore implementation fidelity, mechanisms of impact and contextual factors at patient-level, NH-level and healthcare professional-level, using both quantitative and qualitative measures. The feasibility of the study conduction will be assessed by measuring recruitment and attrition rates and completeness of data collection. An exploratory cost-effectiveness evaluation will be conducted based on quality of life and healthcare use and cost data.

Ethics and dissemination
This study protocol received approval from the ethical committee of CHU UCL Namur on the 20 June 2023. All data are confidential and will be anonymised prior to analysis. De-identified data will be shared on a data depository with a 2-year embargo. The results of the study will be disseminated through a scientific paper and will be communicated to local stakeholders and policymakers through a local symposium.

Trial registration number
NCT05929443.

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