sodium oxybate: Intravenous administration during general anesthesia
Placebo: Intravenous administration during general anesthesia
Study summary
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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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 ≥ 65 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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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