Sex DifferencesNCT05059548
Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia
An observational study of Sex Differences and Postoperative Sleep Quality, run by Shengjing Hospital at 1 site in China.
Trial summary
Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sex Differences, Postoperative Sleep Quality, Postoperative Pain
- What is being tested?
- Video-Assisted Thoracoscopic Surgery
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing video-assisted thoracoscopic surgery under general anesthesia
Who may be able to join
- 18-75 years old
- ASA I-III
- under general anesthesia
Who cannot join
- patients with central nervous system and mental diseases;
- patients with preoperative sleep disturbances;
- patients with a history of sedative, analgesic, or antidepression drug use;
- patients with sleep apnea or moderate and severe obstructive sleep apneahypopnea syndrome;
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital
Shenyang, Liaoning, 110004
junchao zhu, +8618940257257, zhujunchao1@hotmail.com
About this study
Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation, sleep quality and cognitive function among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.
- Conditions
- Sex Differences, Postoperative Sleep Quality, Postoperative Pain, Inflammation Function, Postoperative Cognitive Function
- Being tested
- Video-Assisted Thoracoscopic Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Thoracoscopic SurgeryOther
patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Male Group | Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia Receives: Other: Video-Assisted Thoracoscopic Surgery | |
| Female Group | Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia Receives: Other: Video-Assisted Thoracoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality of one night before surgery
use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)
Measured: one night before surgery
sleep quality of first night after surgery
use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)
Measured: first night after surgery
sleep quality of third night after surgery
use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)
Measured: third night after surgery
preoperative inflammation function
evaluate systemic immune inflammation index (SII) before operation
Measured: three days before surgery
preoperative inflammation function
evaluate neutrophil / lymphocyte ratio (NLR)before operation
Measured: three days before surgery
preoperative inflammation function
evaluate platelet / lymphocyte ratio (PLR) before operation
Measured: three days before surgery
preoperative inflammation function
evaluate monocyte / lymphocyte ratio (MLR) before operation
Measured: three days before surgery
postoperative inflammation function
evaluate systemic immune inflammation index (SII) after operation
Measured: three days after surgery
postoperative inflammation function
evaluate neutrophil / lymphocyte ratio (NLR) after operation
Measured: three days after surgery
postoperative inflammation function
evaluate platelet / lymphocyte ratio (PLR) after operation
Measured: three days after surgery
postoperative inflammation function
evaluate monocyte / lymphocyte ratio (MLR) after operation
Measured: three days after surgery
neuropsychological test
The neuropsychological test battery included the tests used to evaluate patients for delayed neurocognitive recovery in the International Study of Post-Operative Cognitive Dysfunction: (1) word learning: visual verbal learning test based on the Rey's auditory recall of words; (2) word recall: the number or words recalled from visual verbal learning trials after a 20-min delay; (3) cognitive flexibility: including trail making test A and B; (4) distractibility: Stroop color word interference test; and (5) working memory: letter-digit coding. If a patient exhibited delirium at a testing time, neuropsychological evaluation was postponed 3 days.
Measured: Neuropsychological tests were carried out the day before and 5 to 7 days after surgery. The second neuropsychological test time for control subjects was 6 to 9 d
Secondary outcomes (2)
visual analog scale(VAS) score after surgery
evaluate VAS (0-10 points)score 24 hours after surgery
Measured: 24 hours after surgery
postoperative adverse effects
evaluate postoperative adverse effect 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex DifferencesStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- junchao zhu, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059548
- Sponsor's protocol ID
- Sex, cognition, inflammation
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT05059548
- Acronym / sponsor ID
- Sex, cognition, inflammation
- Conditions
- Sex Differences, Postoperative Sleep Quality, Postoperative Pain, Inflammation Function, Postoperative Cognitive Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Sep 2021 (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.
Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation, sleep quality and cognitive function among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male Group | – | Other: Video-Assisted Thoracoscopic SurgeryVideo-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia |
| Female Group | – | Other: Video-Assisted Thoracoscopic SurgeryVideo-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing video-assisted thoracoscopic surgery under general anesthesia
Key inclusion criteria (3 listed)
- 18-75 years old
- ASA I-III
- under general anesthesia
Key exclusion criteria (4 listed)
- patients with central nervous system and mental diseases;
- patients with preoperative sleep disturbances;
- patients with a history of sedative, analgesic, or antidepression drug use;
- patients with sleep apnea or moderate and severe obstructive sleep apneahypopnea syndrome;
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 |
|---|---|---|
| Video-Assisted Thoracoscopic Surgerypatients receive Video-Assisted Thoracoscopic Surgery under general anesthesia | Other | Female Group, Male Group |
Primary outcome
sleep quality of one night before surgery
Time frame: one night before surgery
use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)
sleep quality of first night after surgery
Time frame: first night after surgery
use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)
sleep quality of third night after surgery
Time frame: third night after surgery
use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)
preoperative inflammation function
Time frame: three days before surgery
evaluate systemic immune inflammation index (SII) before operation
preoperative inflammation function
Time frame: three days before surgery
evaluate neutrophil / lymphocyte ratio (NLR)before operation
preoperative inflammation function
Time frame: three days before surgery
evaluate platelet / lymphocyte ratio (PLR) before operation
preoperative inflammation function
Time frame: three days before surgery
evaluate monocyte / lymphocyte ratio (MLR) before operation
postoperative inflammation function
Time frame: three days after surgery
evaluate systemic immune inflammation index (SII) after operation
postoperative inflammation function
Time frame: three days after surgery
evaluate neutrophil / lymphocyte ratio (NLR) after operation
postoperative inflammation function
Time frame: three days after surgery
evaluate platelet / lymphocyte ratio (PLR) after operation
postoperative inflammation function
Time frame: three days after surgery
evaluate monocyte / lymphocyte ratio (MLR) after operation
neuropsychological test
Time frame: Neuropsychological tests were carried out the day before and 5 to 7 days after surgery. The second neuropsychological test time for control subjects was 6 to 9 d
The neuropsychological test battery included the tests used to evaluate patients for delayed neurocognitive recovery in the International Study of Post-Operative Cognitive Dysfunction: (1) word learning: visual verbal learning test based on the Rey's auditory recall of words; (2) word recall: the number or words recalled from visual verbal learning trials after a 20-min delay; (3) cognitive flexibility: including trail making test A and B; (4) distractibility: Stroop color word interference test; and (5) working memory: letter-digit coding. If a patient exhibited delirium at a testing time, neuropsychological evaluation was postponed 3 days.
2 secondary outcomes
visual analog scale(VAS) score after surgery
Time frame: 24 hours after surgery
postoperative adverse effects
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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. This study is not recruiting at the moment.
junchao zhu study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sex Differences and Postoperative Sleep Quality, run by Shengjing Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact junchao zhu (+8618940257257, zhujunchao1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality of one night before surgery (time frame: one night before surgery). The study lists 12 primary outcomes in all. 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 28 Sep 2021.