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

Abstract

Postoperative 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. 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. 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. NCT06451627.