Effects of dexmedetomidine versus remimazolam protocolized sedation during lower limb nerve block on early stress response and quality of recovery in patients undergoing diabetic foot ulcer repair: a randomized controlled trial protocol.

BACKGROUND

For patients undergoing diabetic foot ulcer (DFU) repair, lower limb nerve block is the preferred anesthetic regimen. However, the block alone often fails to fully eliminate intraoperative anxiety and stress responses. Adjunctive procedural sedation and analgesia (PSA), using agents such as dexmedetomidine or remimazolam, is a key strategy to enhance surgical comfort. Nevertheless, the comparative effects of these two agents on early stress response and quality of recovery remain unclear.

METHODS

This is a prospective, randomized, single-center, single-blind, superiority controlled trial. A total of 160 patients aged 18 to 75 years undergoing elective DFU repair will be enrolled and randomized into Group A (dexmedetomidine) and Group B (remimazolam). The primary outcome is the change in serum cortisol levels from preoperative baseline to 2 h postoperatively. Secondary outcomes include the following: vital signs; postoperative pain intensity scores; intraoperative stress level; postoperative quality of recovery; and patient and surgeon satisfaction scores.

DISCUSSION: This study aims to compare the effects of dexmedetomidine and remimazolam PSA on attenuating stress hormone release and improving early postoperative quality of recovery in patients undergoing DFU repair. The future findings will provide high-quality clinical evidence for reducing perioperative stress levels, enhancing patient comfort, and accelerating postoperative recovery.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2500113746. Registered on 2 December 2025.