Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery

ConditionThoracic Surgical Procedures

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorJingsheng Lou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

sodium oxybate
Drug
Intravenous administration during general anesthesia
Placebo
Drug
Intravenous administration during general anesthesia

Treatment groups

360 Participants

are divided into 2 treatment groups

Group A: Sodium oxybate groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Morning of Post-Operative Day 1 (POD1)

Secondary outcomes

Sleep efficiency (SE%)

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

Time frame

First Post-Operative Night

Total sleep time (TST, minutes)

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

Time frame

First Post-Operative Night

Wake After Sleep Onset (WASO, minutes)

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

Time frame

First Post-Operative Night

Sleep Latency (SL, minutes)

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

Time frame

First Post-Operative Night

Other outcomes

Incidence and severity of postoperative delirium

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.

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)

Total intraoperative consumption of anesthetic agents

Cumulative intraoperative consumption of propofol and remifentanil.

Time frame

Intraoperative period

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

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.

Time frame

Morning of Post-Operative Day 3 (POD3)

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).

Time frame

Incidence of peri-operative adverse events

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jingsheng Lou

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov

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