Hydrocortisone for the prevention of postoperative delirium in digestive surgery (HyPOD): study protocol for a multicentre randomised, blinded, placebo-controlled trial.

INTRODUCTION

Postoperative delirium (POD) is a significant complication in digestive surgery, potentially increasing hospital stays, costs and mortality. Corticoids, such as dexamethasone and methylprednisolone, have been reported to reduce POD. However, the efficacy of hydrocortisone (HC) remains unexplored. This trial aims to evaluate HC's effectiveness in preventing POD in surgical patients.

METHODS AND ANALYSIS: A multicentre (three hospitals), randomised, blinded (patient-blinded, surgeon-blinded, anaesthesiologist-blinded and monitor-blinded), placebo-controlled trial of HC for the prevention of POD in patients undergoing digestive surgery was started in June 2024. Patients undergoing digestive surgery are randomly assigned to the HC or placebo group. The stratification factors are age, sex, disease stage and procedure type. Before skin incision, the participants in the HC group are administered 500 mg HC intravenously. The participants in the placebo group are administered the same volume of saline that is indistinguishable from the HC. The primary outcome is the presence of POD from postoperative days 1 to 3, which is assessed using the Confusion Assessment Method-ICU (CAM-ICU). The secondary outcomes are changes in serum sodium levels, postoperative mortality, length of hospital stay, functional independence measures and complications within 28 days. To date, 61 patients of a planned 180 have been enrolled in the study.

ETHICS AND DISSEMINATION: This protocol was approved by the Nagoya University Clinical Research Review Board and was registered with the Japan Registry of Clinical Trials on 24 May 2024. The results of this trial will be disseminated through peer-reviewed journals.

TRIAL REGISTRATION NUMBER: jRCTs041240032.