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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Intravenous administration during general anesthesia
Intravenous administration during general anesthesia
Chinese PLA General Hospital
Beijing, China
Subjective sleep quality on 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.
Time frame: Morning of Post-Operative Day 1 (POD1)
Sleep efficiency (SE%)
Sleep efficiency (SE%) derived from wrist-worn actigraphy.
Time frame: First Post-Operative Night
Total sleep time (TST, minutes)
Total sleep time (TST, minutes) derived from wrist-worn actigraphy.
Time frame: First Post-Operative Night
Wake After Sleep Onset (WASO, minutes)
Wake After Sleep Onset (WASO, minutes) derived from wrist-worn actigraphy.
Time frame: First Post-Operative Night
Sleep Latency (SL, minutes)
Sleep Latency (SL, minutes) derived from wrist-worn actigraphy.
Time frame: First Post-Operative Night
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