Thoracic Surgical Procedures
Conditions
Keywords
sodium oxybate, postoperative sleep quality, thoracoscopic surgery, peri-operative anesthesia
Brief 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.
Detailed 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.
Interventions
DRUGsodium oxybate
Intravenous administration during general anesthesia
DRUGPlacebo
Intravenous administration during general anesthesia
Sponsors
Jingsheng Lou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency (SE%) | First Post-Operative Night | Sleep efficiency (SE%) derived from wrist-worn actigraphy. |
| Total sleep time (TST, minutes) | First Post-Operative Night | Total sleep time (TST, minutes) derived from wrist-worn actigraphy. |
| Wake After Sleep Onset (WASO, minutes) | First Post-Operative Night | Wake After Sleep Onset (WASO, minutes) derived from wrist-worn actigraphy. |
| Sleep Latency (SL, minutes) | First Post-Operative Night | Sleep Latency (SL, minutes) derived from wrist-worn actigraphy. |
Countries
China
Contacts
CONTACTJiangbei Cao, MD
CONTACTWeixing Zhao, MD
PRINCIPAL_INVESTIGATORJiangbei Cao, MD
Chinese PLA General Hospital
STUDY_DIRECTORWeixing Zhao, MD
Chinese PLA General Hospital
Outcome results
None listed