Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia

Sponsor
Shengjing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05059548
Collaborator
(none)
100
1
3.4
29.8

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video-Assisted Thoracoscopic Surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia
Anticipated Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Male Group

Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Other: Video-Assisted Thoracoscopic Surgery
patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Female Group

Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Other: Video-Assisted Thoracoscopic Surgery
patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Outcome Measures

Primary Outcome Measures

  1. sleep quality of one night before surgery [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)

  2. sleep quality of first night after surgery [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)

  3. sleep quality of third night after surgery [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)

  4. preoperative inflammation function [three days before surgery]

    evaluate systemic immune inflammation index (SII) before operation

  5. preoperative inflammation function [three days before surgery]

    evaluate neutrophil / lymphocyte ratio (NLR)before operation

  6. preoperative inflammation function [three days before surgery]

    evaluate platelet / lymphocyte ratio (PLR) before operation

  7. preoperative inflammation function [three days before surgery]

    evaluate monocyte / lymphocyte ratio (MLR) before operation

  8. postoperative inflammation function [three days after surgery]

    evaluate systemic immune inflammation index (SII) after operation

  9. postoperative inflammation function [three days after surgery]

    evaluate neutrophil / lymphocyte ratio (NLR) after operation

  10. postoperative inflammation function [three days after surgery]

    evaluate platelet / lymphocyte ratio (PLR) after operation

  11. postoperative inflammation function [three days after surgery]

    evaluate monocyte / lymphocyte ratio (MLR) after operation

  12. neuropsychological test [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.

Secondary Outcome Measures

  1. visual analog scale(VAS) score after surgery [24 hours after surgery]

    evaluate VAS (0-10 points)score 24 hours after surgery

  2. postoperative adverse effects [24 hours after surgery]

    evaluate postoperative adverse effect 24 hours after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18-75 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 apneahypopnea syndrome;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shengjing Hospital Shenyang Liaoning China 110004

Sponsors and Collaborators

  • Shengjing Hospital

Investigators

  • Study Director: junchao zhu, Shengjing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanchao Yang, principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT05059548
Other Study ID Numbers:
  • Sex, cognition, inflammation
First Posted:
Sep 28, 2021
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021