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Background <p>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.</p> Methods <p>This multicentre, randomized, double-blind, placebo-controlled trial will enroll 560 patients aged 65–90&#xa0;years undergoing hip-fracture surgery. Participants will be randomly assigned (1:1) to receive an overnight infusion of dexmedetomidine 0.2&#xa0;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&#xa0;h, assessed every 6&#xa0;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&#xa0;days, and plasma biomarkers.</p> Discussion <p>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.</p> Trial registration <p>Chinese Clinical Trial Registry ChiCTR2400087107. Registered on 19 July 2024.</p>

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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

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  • 出版模式：

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  • 发表日期：

    2026年3月9日

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  • Jin-chao Song,
  • Guo-pan Zhang,
  • Tong Ding,
  • Jun Lu,
  • Yi-yu He,
  • Xiaoyan Meng

摘要

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.