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Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery

RecruitingNAAges 18 Years - anyAllJingsheng Lou
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ18 years old. * American Society of Anesthesiologists (ASA) physical status โ… -โ…ข. * Baseline cognitive function: Mini-Mental State Examination (MMSE) score โ‰ฅ 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.
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What it tests

  • sodium oxybate
  • Placebo
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Where

1 site
Chinese PLA General Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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