Effect of esketamine on postoperative sleep disturbance in patients undergoing spinal surgery: a study protocol for a randomised, double-blinded, placebo-controlled clinical trial.

introductionPostoperative sleep disturbance (PSD) is a common complication after spinal surgery that can be related to postsurgical pain, perioperative anxiety and depression. Recent studies have shown that esketamine may improve sleep disturbance after surgery; however, it remains unclear whether intraoperative infusion of esketamine can improve the postoperative sleep quality of patients undergoing spinal surgery. METHODS AND ANALYSIS: This is a protocol for a randomised, double-blinded, placebo-controlled clinical trial to evaluate the effect of esketamine on PSD in patients undergoing spinal surgery. Patients aged 18-65 years who plan to undergo selective spinal surgery will be randomly allocated to the esketamine group or control group at a ratio of 1:1. Esketamine or saline will be infused at the same speed of 0.3 mg/kg/hour during the surgery by the anaesthesiologists in charge, who are blinded to the randomisation. The primary outcome of the study is the incidence of PSD during the first 3 days after surgery. The secondary outcomes include objective sleep quality, numeric rating scale scores, dosage of analgesics and Hospital Anxiety and Depression Scale scores. ETHICS AND DISSEMINATION: The study was approved by the Ethical Committee of Beijing Tiantan Hospital, Capital Medical University (KY2024-013-02),Beijing, China. The study was registered on ClinicalTrials.gov on 4 June 2024 (NCT06451627). Our study might guide perioperative anaesthesia management plans and improve PSD in patients undergoing spinal surgery. The findings of the study will be published in peer-reviewed journals and will be presented at national or international conferences. TRIAL REGISTRATION NUMBER: NCT06451627.