Overview
This is a single-center, randomized, double-blind, placebo-controlled trial. Three hundred-sixty adult patients undergoing elective thoracoscopic surgery will be randomly allocated at a 1:1 ratio to receive either intraoperative sodium oxybate or placebo. The primary objective is to compare postoperative sleep quality between the two groups. Secondary outcomes include postoperative pain scores, incidence of adverse events and other peri-operative indicators.
Description
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.
Eligibility
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.
