Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07794982

Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Thoracic Surgical Procedures

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Oxybate

Drug

Intravenous administration during general anesthesia

Placebo

Drug

Intravenous administration during general anesthesia

Primary outcomes

  1. Subjective sleep quality on Post-Operative Day 1 (POD1)

    Time frame: 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 outcomes

  1. Sleep efficiency (SE%)

    Time frame: First Post-Operative Night

    Sleep efficiency (SE%) derived from wrist-worn actigraphy.

  2. Total sleep time (TST, minutes)

    Time frame: First Post-Operative Night

    Total sleep time (TST, minutes) derived from wrist-worn actigraphy.

  3. Wake After Sleep Onset (WASO, minutes)

    Time frame: First Post-Operative Night

    Wake After Sleep Onset (WASO, minutes) derived from wrist-worn actigraphy.

  4. Sleep Latency (SL, minutes)

    Time frame: First Post-Operative Night

    Sleep Latency (SL, minutes) derived from wrist-worn actigraphy.

Other outcomes

  1. Incidence and severity of postoperative delirium

    Time frame: Twice daily (Morning 08:00-10:00 and Evening 18:00-20:00), covering Post-Operative Day 1 (POD1), Post-Operative Day 2 (POD2), Post-Operative Day 3 (POD3)

    Incidence and severity of postoperative delirium assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM). This tool yields a binary diagnosis of delirium (present or absent), as well as grading for delirium severity.

  2. Total intraoperative consumption of anesthetic agents

    Time frame: Intraoperative period

    Cumulative intraoperative consumption of propofol and remifentanil.

  3. Post-operative Quality of Recovery-15 (QoR-15) score

    Time frame: Morning of Post-Operative Day 3 (POD3)

    Post-operative recovery quality assessed by the Post-operative Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150. Higher scores indicate better postoperative recovery quality.

  4. Incidence of peri-operative adverse events

    Time frame: Incidence of peri-operative adverse events

    From study drug administration to hospital discharge, up to POD7 Description: Postoperative nausea and vomiting (PONV); respiratory depression (SpO2 <90% lasting >2 min); delayed emergence (Steward recovery score <4 lasting >30 min post-extubation); bradycardia (HR <50 bpm); hypothermia (core temp <35.5℃); electrolyte disorders (hypokalemia, hyponatremia); and Serious Adverse Events (SAEs).

  5. Intra-operative core body temperature

    Time frame: From completion of endotracheal intubation until the end of surgical procedure

    Intra-operative core body temperature measured during surgery.

  6. Incidence and severity of post-anesthetic shivering

    Time frame: From the end of surgical procedure until prior to ward transfer

    Incidence and severity grading of post-anesthetic shivering.

  7. Fasting blood glucose

    Time frame: Baseline (morning on the day of surgery), morning of Post-Operative Day 1 (POD1))

    Peripheral fasting blood glucose concentration.

  8. Blood lactate

    Time frame: Baseline (morning on the day surgery, fasting state), morning of Post-Operative Day 1 (POD1)

    Peripheral blood lactate concentration.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiangbei Cao, MD

CONTACT

[email protected]

+86-10-01066937485

Weixing Zhao, MD

CONTACT

[email protected]

+86-10-01066937485

Sponsors and collaborators

Lead sponsor

Jingsheng Lou

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.