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

NCT05059548 — Unknown, 100 participants, Shengjing Hospital

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Registry	NCT05059548
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Shengjing Hospital (Other)
Conditions	Sex Differences, Postoperative Sleep Quality, Postoperative Pain, Inflammation Function, Postoperative Cognitive Function
Interventions	Video-Assisted Thoracoscopic Surgery (Other)
Dates	start 2021-09-20 (estimated), primary completion 2021-12-31 (estimated), completion 2021-12-31 (estimated), first posted 2021-09-28, last updated 2021-09-28
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Male Group		Other: Video-Assisted Thoracoscopic Surgery	Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
Female Group		Other: Video-Assisted Thoracoscopic Surgery	Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

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

+Outcome measures

Primary outcomes

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)
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)
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)
preoperative inflammation function [three days before surgery]: evaluate systemic immune inflammation index (SII) before operation
preoperative inflammation function [three days before surgery]: evaluate neutrophil / lymphocyte ratio (NLR)before operation
preoperative inflammation function [three days before surgery]: evaluate platelet / lymphocyte ratio (PLR) before operation
preoperative inflammation function [three days before surgery]: evaluate monocyte / lymphocyte ratio (MLR) before operation
postoperative inflammation function [three days after surgery]: evaluate systemic immune inflammation index (SII) after operation
postoperative inflammation function [three days after surgery]: evaluate neutrophil / lymphocyte ratio (NLR) after operation
postoperative inflammation function [three days after surgery]: evaluate platelet / lymphocyte ratio (PLR) after operation
postoperative inflammation function [three days after surgery]: evaluate monocyte / lymphocyte ratio (MLR) after operation
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 outcomes

visual analog scale(VAS) score after surgery [24 hours after surgery]: evaluate VAS (0-10 points)score 24 hours after surgery
postoperative adverse effects [24 hours after surgery]: evaluate postoperative adverse effect 24 hours after surgery

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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;

+Locations (1)

Facility	City	Country	Status
Shengjing Hospital	Shenyang, Liaoning	China

+Investigators

junchao zhu, Study director, Shengjing Hospital