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

• Conditions: Postoperative Pain; Inflammation Function; Postoperative Cognitive Function; Sex Differences; Postoperative Sleep Quality
• Interventions: Other: Video-Assisted Thoracoscopic Surgery

• Registration Number: NCT05059548
• Lead Sponsor: Shengjing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study Start: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Last Update Submitted: 2021-09-20
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18-75 years old
• ASA I-III
• under general anesthesia

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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;

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male Group	Video-Assisted Thoracoscopic Surgery	Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
Female Group	Video-Assisted Thoracoscopic Surgery	Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Primary Outcome Measures

Name	Time	Method
preoperative inflammation function	three days before surgery	evaluate monocyte / lymphocyte ratio (MLR) before 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.
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)
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 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)
postoperative inflammation function	three days after surgery	evaluate monocyte / lymphocyte ratio (MLR) after operation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China