Nocturnal dexmedetomidine infusion versus placebo for prevention of postoperative delirium in elderly patients undergoing hip-fracture surgery: a protocol for a multicentre, randomized, double-blind trial

Abstract

Background: Postoperative delirium (POD) is common after hip-fracture surgery in older adults and is associated with prolonged hospitalization, increased mortality, and long-term cognitive decline. Previous literature has indicated that dexmedetomidine may reduce delirium when given intra-operatively; however, the benefit of a single nocturnal infusion before surgery has not been evaluated. We hypothesize that pre-operative night-time dexmedetomidine improves sleep quality and attenuates neuro-inflammation, thereby decreasing POD incidence. Methods: This multicentre, randomized, double-blind, placebo-controlled trial will enroll 560 patients aged 65–90 years undergoing hip-fracture surgery. Participants will be randomly assigned (1:1) to receive an overnight infusion of dexmedetomidine 0.2 µg/kg·h or matching saline from 20:00 to 06:00 a.m. before surgery. The primary endpoint is the incidence of POD during the first 72 h, assessed every 6 h with the 3-Minute Diagnostic Confusion Assessment Method and the relative risk (95% CI) will be calculated using the chi-square test. Secondary outcomes include delirium severity and duration, pain scores, sleep quality, cognitive function at 30 and 180 days, and plasma biomarkers. Discussion: This protocol evaluates whether the night-before infusion of dexmedetomidine prevents POD in older adults undergoing hip-fracture surgery. If effective, the intervention could easily be implemented in routine peri-operative care. Trial registration: Chinese Clinical Trial Registry ChiCTR2400087107. Registered on 19 July 2024.