Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery

NCT07794982 | Not Yet Recruiting

• 1 other identifier: S2026-556-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgical Procedures

Keywords

sodium oxybate; postoperative sleep quality; thoracoscopic surgery; peri-operative anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Morning of Post-Operative Day 1 (POD1)

Secondary Outcomes (4)

• Sleep efficiency (SE%)

  First Post-Operative Night

• Total sleep time (TST, minutes)

  First Post-Operative Night

• Wake After Sleep Onset (WASO, minutes)

  First Post-Operative Night

• Sleep Latency (SL, minutes)

  First Post-Operative Night

Other Outcomes (8)

• Incidence and severity of postoperative delirium

  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)

• Total intraoperative consumption of anesthetic agents

  Intraoperative period

• Post-operative Quality of Recovery-15 (QoR-15) score

  Morning of Post-Operative Day 3 (POD3)

Study Arms (2)

Sodium oxybate group

EXPERIMENTAL

Intravenous sodium oxybate administered during general anesthesia

Drug: sodium oxybate

Placebo group

PLACEBO COMPARATOR

Intravenous placebo administered during general anesthesia

Drug: Placebo

Interventions

sodium oxybate DRUG

Intravenous administration during general anesthesia

Sodium oxybate group

Placebo DRUG

Intravenous administration during general anesthesia

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jingsheng Lou: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

MeSH Terms

Interventions

Sodium Oxybate

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Jiangbei Cao, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Weixing Zhao, MD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiangbei Cao, MD

CONTACT

+86-10-01066937485; cjb2000@sina.com

Weixing Zhao, MD

CONTACT

+86-10-01066937485; 1325859408@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)