Thoracic Surgical ProceduresNCT07794982
Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery
A study testing sodium oxybate in people with Thoracic Surgical Procedures, run by Jingsheng Lou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgical Procedures
- What is being tested?
- sodium oxybate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Jiangbei Cao, MD, +86-10-01066937485, cjb2000@sina.com
Weixing Zhao, MD, +86-10-01066937485, 1325859408@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Thoracic Surgical Procedures
- Being tested
- sodium oxybate, Placebo
- Keywords
- sodium oxybate, postoperative sleep quality, thoracoscopic surgery, peri-operative anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium oxybateDrug
Intravenous administration during general anesthesia
PlaceboDrug
Intravenous administration during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Sodium oxybate group | Experimental | Intravenous sodium oxybate administered during general anesthesia Receives: Drug: sodium oxybate |
| Placebo group | Placebo comparator | Intravenous placebo administered during general anesthesia Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Morning of Post-Operative Day 1 (POD1)
Secondary outcomes (4)
Sleep efficiency (SE%)
Sleep efficiency (SE%) derived from wrist-worn actigraphy.
Measured: First Post-Operative Night
Total sleep time (TST, minutes)
Total sleep time (TST, minutes) derived from wrist-worn actigraphy.
Measured: First Post-Operative Night
Wake After Sleep Onset (WASO, minutes)
Wake After Sleep Onset (WASO, minutes) derived from wrist-worn actigraphy.
Measured: First Post-Operative Night
Sleep Latency (SL, minutes)
Sleep Latency (SL, minutes) derived from wrist-worn actigraphy.
Measured: First Post-Operative Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingsheng Lou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingsheng Lou, Chinese PLA General Hospital
- Investigators
- Jiangbei Cao, MD, Principal investigator, Chinese PLA General HospitalWeixing Zhao, MD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794982
- Sponsor's protocol ID
- S2026-556-01
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07794982
- Acronym / sponsor ID
- S2026-556-01
- Conditions
- Thoracic Surgical Procedures
- Keywords
- sodium oxybate, postoperative sleep quality, thoracoscopic surgery, peri-operative anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Jingsheng LouUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium oxybate group | Experimental | Drug: sodium oxybateIntravenous sodium oxybate administered during general anesthesia |
| Placebo group | Placebo comparator | Drug: PlaceboIntravenous placebo administered during general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium oxybateIntravenous administration during general anesthesia | Drug | Sodium oxybate group |
| PlaceboIntravenous administration during general anesthesia | Drug | Placebo group |
Primary outcome
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.
4 secondary outcomes
Sleep efficiency (SE%)
Time frame: First Post-Operative Night
Total sleep time (TST, minutes)
Time frame: First Post-Operative Night
Wake After Sleep Onset (WASO, minutes)
Time frame: First Post-Operative Night
Sleep Latency (SL, minutes)
Time frame: First Post-Operative Night
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiangbei Cao, MD principal investigator
Chinese PLA General Hospital
Weixing Zhao, MD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium oxybate in people with Thoracic Surgical Procedures, run by Jingsheng Lou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiangbei Cao, MD (+86-10-01066937485, cjb2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sleep quality on Post-Operative Day 1 (POD1) (time frame: Morning of Post-Operative Day 1 (POD1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.