Effects of oxycodone versus sufentanil on postoperative sleep quality and analgesia in patients after modified radical mastectomy: study protocol for a randomized, double-blind, controlled trial using wearable sleep monitoring

Background Postoperative sleep disorder, a frequently observed complication, is associated with heightened pain sensitivity, exacerbated inflammatory reactions, and compromised tissue repair. Sufentanil, a highly selective -opioid receptor agonist, is widely used in patient-controlled intravenous analgesia (PCIA) and has been associated with reduced sleep efficiency. Oxycodone, as a /{kappa} dual receptor agonist, has shown a lower incidence of adverse effects in clinical practice. Despite these pharmacological differences, the comparative effects of oxycodone- versus sufentanil-based PCIA on postoperative sleep remain poorly characterized. Recent advances in wearable devices demonstrate strong agreement with polysomnography (PSG) in intergroup comparisons of sleep efficiency and total sleep time, enabling continuous, non-invasive, multi-night sleep monitoring and offering a viable alternative for clinical postoperative sleep research. Hence, we design this clinical trial to compare postoperative sleep efficiency between patients receiving oxycodone-based versus sufentanil-based PCIA under wearable sleep monitoring. Methods This study is a randomized, double-blind, placebo-controlled trial that was conducted at a single center. A sample size of 68 patients was determined through calculation, and these patients will be randomly assigned to either the oxycodone group or the sufentanil group. Sleep monitoring was initiated using a wristband device one day before surgery after recruitment. The sleep quality data at different setting time will be monitored. All patients will be followed up by blinded evaluators at baseline and 1, 2, and 30 days after the intervention. The follow-up included pain scores, postoperative complications and adverse events, etc. Discussion By integrating a modern photoelectric device with first-line analgesics, we hope the result of the study will inform perioperative sleep management, guide clinical analgesic selection, and improve patient recovery quality.