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NCT Number: NCT04608435

Sex Differences in Postoperative Sleep Quality and Inflammation

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 and sleep quality among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.

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Key information

Conditions

Sex Differences Inflammation Function Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Postoperative Sleep Quality Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 years old
  • ASA I-III
  • under general anesthesia

Exclusion criteria

  • 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 apnea-hypopnea syndrome;

Treatment and study plan

Video-Assisted Thoracoscopic Surgery

Other

patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Primary outcomes

  1. sleep quality of one night before surgery

    Time frame: first night before surgery

    Use Athens insomnia scale to test the sleep quality the first night before surgery

  2. sleep quality of first night after surgery

    Time frame: first night after surgery

    Use Athens insomnia scale to test the sleep quality the first night after surgery

  3. sleep quality of third night after surgery

    Time frame: third night after surgery

    Use Athens insomnia scale to test the sleep quality the third night after surgery

Secondary outcomes

  1. visual analog scale(VAS) score after surgery

    Time frame: one day before surgery

    evaluate VAS score after surgery

  2. visual analog scale(VAS) score after surgery

    Time frame: 3 hours after surgery

    evaluate VAS score after surgery

  3. visual analog scale(VAS) score after surgery

    Time frame: 8 pm the first day after surgery

    evaluate VAS score after surgery

  4. postoperative adverse effect

    Time frame: 24 hours after surgery

    evaluate postoperative adverse effect 24 hours after surgery

  5. perioperative inflammation function

    Time frame: two days before surgery

    evaluate neutrophils

  6. perioperative inflammation function

    Time frame: two days before surgery

    evaluate platelet

  7. perioperative inflammation function

    Time frame: two days before surgery

    evaluate lymphocyte

  8. perioperative inflammation function

    Time frame: first days after surgery

    evaluate neutrophils,platelet,lymphocyte

  9. perioperative inflammation function

    Time frame: first days after surgery

    evaluate neutrophils

  10. perioperative inflammation function

    Time frame: first days after surgery

    evaluate platelet

  11. perioperative inflammation function

    Time frame: first days after surgery

    evaluate lymphocyte

  12. Postoperative cognition evaluation

    Time frame: one day before surgery

    Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.

  13. Postoperative cognition evaluation

    Time frame: first day after surgery

    Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.

  14. Postoperative cognition evaluation

    Time frame: third day after surgery

    Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2020
Registry last updated
May 4, 2022

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.

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