Sodium Oxybate to Improve Sleep After Thoracic Surgery
Official title: Effect of Single Intraoperative Infusion of Sodium Oxybate on Postoperactive Sleep Disturbance in Patients Undergoing Elective Thoracoscopic Lobectomy or Segmentectomy: A Single-center,Randomized,Double-blind,Placebo-controlled Clinical Trial
Run by Chinese PLA General Hospital · NCT07794982 · Data updated 2026-11-12
In adults having elective thoracoscopic surgery, this study tests whether giving sodium oxybate during operation improves sleep quality after surgery compared with a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07794982 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) scheduled for elective VATS lobectomy or segmentectomy under general anesthesia, with ASA I–III and adequate baseline cognition.
✕Probably not a fit
Patients with contraindications to sleep aids, those undergoing surgeries ending late in the day, or those with significant CNS disease may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled trial enrolling 360 adults undergoing elective VATS lobectomy or segmentectomy. Participants are assigned 1:1 to receive intraoperative sodium oxybate or placebo. The primary goal is to see if postoperative sleep quality improves with sodium oxybate, while secondary outcomes include pain scores, safety events, and other peri-operative indicators. Sodium oxybate is evaluated for its potential to improve recovery by stabilizing sleep after surgery and is assessed for safety in the perioperative period.
Why it matters
Potential benefit: If successful, patients may experience better sleep after thoracic surgery, which could support faster recovery and lower pain.
How similar studies have gone: Past studies of similar sedative-hypnotic approaches in perioperative care have shown mixed results; this trial tests a specific intraoperative use of sodium oxybate.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Chinese PLA General Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Jiangbei Cao, MD — Chinese PLA General Hospital
- Study coordinator: Jiangbei Cao, MD
- Email: cjb2000@sina.com
- Phone: +86-10-01066937485
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.