Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery

Postoperative sleep disturbance is common after thoracoscopic surgery, which may aggravate pain response and impair postoperative recovery. Sodium oxybate is a sedative-hypnotic agent. This trial intends to explore whether intraoperative administration of sodium oxybate can improve postoperative sleep quality in surgical patients, and to evaluate its peri-operative safety.

• sodium oxybate (Drug): Intravenous administration during general anesthesia
• Placebo (Drug): Intravenous administration during general anesthesia

Primary outcomes

• Subjective sleep quality on Post-Operative Day 1 (POD1) [Morning of Post-Operative Day 1 (POD1)]: Subjective sleep quality on Post-Operative Day 1 (POD1), measured by the Richards-Campbell Sleep Questionnaire (RCSQ) total score. The RCSQ total score is the mean value of the first 5 items, ranging from 0 to 100. Higher scores indicate better subjective sleep quality.

Secondary outcomes

• Sleep efficiency (SE%) [First Post-Operative Night]: Sleep efficiency (SE%) derived from wrist-worn actigraphy.
• Total sleep time (TST, minutes) [First Post-Operative Night]: Total sleep time (TST, minutes) derived from wrist-worn actigraphy.
• Wake After Sleep Onset (WASO, minutes) [First Post-Operative Night]: Wake After Sleep Onset (WASO, minutes) derived from wrist-worn actigraphy.
• Sleep Latency (SL, minutes) [First Post-Operative Night]: Sleep Latency (SL, minutes) derived from wrist-worn actigraphy.

Other outcomes

• Incidence and severity of postoperative delirium [Twice daily (Morning 08:00-10:00 and Evening 18:00-20:00), covering Post-Operative Day 1 (POD1), Post-Operative Day 2 (POD2), Post-Operative Day 3 (POD3)]: Incidence and severity of postoperative delirium assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM). This tool yields a binary diagnosis of delirium (present or absent), as well as grading for delirium severity.
• Total intraoperative consumption of anesthetic agents [Intraoperative period]: Cumulative intraoperative consumption of propofol and remifentanil.
• Post-operative Quality of Recovery-15 (QoR-15) score [Morning of Post-Operative Day 3 (POD3)]: Post-operative recovery quality assessed by the Post-operative Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150. Higher scores indicate better postoperative recovery quality.
• Incidence of peri-operative adverse events [Incidence of peri-operative adverse events]: From study drug administration to hospital discharge, up to POD7 Description: Postoperative nausea and vomiting (PONV); respiratory depression (SpO2 <90% lasting >2 min); delayed emergence (Steward recovery score <4 lasting >30 min post-extubation); bradycardia (HR <50 bpm); hypothermia (core temp <35.5℃); electrolyte disorders (hypokalemia, hyponatremia); and Serious Adverse Events (SAEs).
• Intra-operative core body temperature [From completion of endotracheal intubation until the end of surgical procedure]: Intra-operative core body temperature measured during surgery.
• Incidence and severity of post-anesthetic shivering [From the end of surgical procedure until prior to ward transfer]: Incidence and severity grading of post-anesthetic shivering.
• Fasting blood glucose [Baseline (morning on the day of surgery), morning of Post-Operative Day 1 (POD1))]: Peripheral fasting blood glucose concentration.
• Blood lactate [Baseline (morning on the day surgery, fasting state), morning of Post-Operative Day 1 (POD1)]: Peripheral blood lactate concentration.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients scheduled for elective VATS lobectomy or segmentectomy under general anesthesia, who provide written informed consent, with anticipated surgical duration > 1 hour.
* Age ≥18 years old.
* American Society of Anesthesiologists (ASA) physical status Ⅰ-Ⅲ.
* Baseline cognitive function: Mini-Mental State Examination (MMSE) score ≥ 17, adjusted for educational level.

Exclusion Criteria:

* History of chronic alcohol abuse or illicit substance use.
* Surgical completion time at or after 20:00.
* History of central nervous system diseases (epilepsy, Parkinson's disease, dementia, prior stroke) or prior neurosurgical procedures.
* Post-operative unplanned intensive care unit (ICU) admission.
* Regular pre-operative use of sodium oxybate, benzodiazepines or other potent central nervous system depressants, unless discontinued for at least 5 elimination half-lives before surgery.

• Jiangbei Cao, MD, Principal investigator, Chinese PLA General Hospital
• Weixing Zhao, MD, Study director, Chinese PLA General Hospital