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.

Ischaemic heart disease (IHD) is a leading cause of morbidity and mortality worldwide. Despite strong recommendations, the implementation rate of outpatient cardiac rehabilitation (CR) in Japan remains low. Mobile health technologies, such as Personal Health Record (PHR) applications combined with wearable devices, may enhance adherence to rehabilitation programmes. This study aims to evaluate the effectiveness of a continuous support programme that integrates a PHR app and counselling services in improving the continuation rate of outpatient CR and exercise tolerance in patients with IHD.

This is a single-blind randomised controlled trial with a parallel-group design. A total of 72 participants with IHD will be recruited from the outpatient departments of Maebashi Red Cross Hospital, Gunma Saiseikai Maebashi Hospital, Okayama University Hospital, Okayama Red Cross Hospital, Momoyama-kai Ono Internal Clinic, Hiroshima University Hospital, Tshuyama Jifu-kai Tsuyama Chuo Hospital and Shinpu-kai Tamashima Chuo Hospital. Participants will be randomly allocated to either the intervention group, which will receive a wearable device, a PHR app, counselling services and a rehabilitation notebook, or the control group, which will receive a wearable device and a rehabilitation notebook without the PHR app and counselling. The primary outcome is the change in peak oxygen uptake from baseline to 150 days. Secondary outcomes include changes in anaerobic threshold, number of outpatient rehabilitation visits, daily steps and vital signs. Data will be analysed using a generalised estimating equations for primary outcomes and appropriate statistical tests for secondary outcomes, following an intention-to-treat approach.

Ethical approval for this study was obtained from the ethics committee of the Kyoto University Graduate School and Faculty of Medicine (C1669-1). In addition, permission to conduct the study was granted by the director of each participating institution. Participants will provide informed consent prior to participation. Findings will be disseminated through peer-reviewed journals, conferences and summary reports to stakeholders.

This trial is registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (trial identifier: UMIN000055823).