With the rapid increase in the ageing population, the use of procedural sedation and analgesia (PSA) for diagnostic procedures such as prostate biopsy in older adults is increasing. However, elderly patients are particularly susceptible to respiratory depression during PSA testing and have a significantly higher risk of hypoxaemia during procedures requiring deep sedation. Although propofol combined with fentanyl is commonly used, it frequently causes hypoxaemia and apnoea. Remimazolam, a novel ultrashort-acting benzodiazepine, may be a safer alternative with less respiratory compromise; however, the supporting evidence remains limited. This study aims to assess whether remimazolam combined with fentanyl reduces the incidence of respiratory depression compared with propofol combined with fentanyl in elderly patients undergoing prostate biopsy under deep sedation requiring immobility.

This is a single-centre, participant and assessor-blinded (with pragmatic blinding of participants), parallel-group, superiority randomised controlled trial conducted at the Jichi Medical University Saitama Medical Centre, Japan. Eligible participants are men aged ≥70 years who are scheduled to undergo prostate biopsy under intravenous sedation. Participants will be randomised in a 1:1 ratio to receive either remimazolam or propofol, each administered in combination with fentanyl at a fixed effect-site concentration. The primary outcome is the incidence of severe apnoea (≥1 min). The primary analysis will follow the intention-to-treat principle, implemented practically as a full analysis set analysed using a complete case approach. Sensitivity analyses will include a per-protocol analysis and multiple imputations of missing data. A subgroup analysis of patients aged ≥75 years was performed.

This study was approved by the Jichi Medical University Central Clinical Research Ethics Committee (approval number: 24JMU001S-2) and was registered with the Japan Registry of Clinical Trials on 11 November 2024. Written informed consent was obtained from all participants before enrolment. These findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

jRCTs031240478.

High-risk pregnant women with physical or obstetric complications may develop depression and anxiety disorders that may worsen depending on the consequences of treatment and management during pregnancy. Therefore, their psychological well-being requires particular attention under these conditions. Consideration of specific and effective interventions for depression and anxiety would help improve the psychological outcomes of these women. This review aims to evaluate the effectiveness of cognitive behavioural therapy-based interventions for depression and anxiety in high-risk pregnant women.

This systematic review will follow the Joanna Briggs Institute (JBI) methodology for systematic reviews of effectiveness. The searches will be conducted in English in the following databases: MEDLINE, CINAHL, Web of Science, PsycINFO and Cochrane Central Register of Controlled Trials. Additionally, the Ichushi Web will be searched in English and Japanese. Sources of unpublished studies will be searched using ClinicalTrials.gov and the UMIN Clinical Trials Registry. Grey literature will be searched using DANS Data Stations. The JBI guidelines will be used for screening studies, study selection, critical appraisal, data extraction and integration. The Grading of Recommendations, Assessment, Development and Evaluation approach will be used to evaluate the certainty of the findings by two independent reviewers. If possible, statistical meta-analyses will be pooled. Additionally, the statistical heterogeneity will be assessed. Subgroup analysis will be performed according to participant and intervention characteristics. Funnel plots, Egger, Begg and Harbord tests will be used to detect publication bias, if necessary.

This systematic review does not require an ethics approval, as the data will be evaluated from previously published studies. The findings will be disseminated through publication in an international peer-reviewed journal and presented at research conferences.

CRD42024522468.