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

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 Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Postoperative Sleep Quality; Sex Differences; Postoperative Cognitive Function; Inflammation Function
• Intervention / Treatment: Other: Video-Assisted Thoracoscopic Surgery

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing video-assisted thoracoscopic surgery under general anesthesia

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	third night after surgery
preoperative inflammation function	evaluate systemic immune inflammation index (SII) before operation	three days before surgery
preoperative inflammation function	evaluate neutrophil / lymphocyte ratio (NLR)before operation	three days before surgery
preoperative inflammation function	evaluate platelet / lymphocyte ratio (PLR) before operation	three days before surgery
preoperative inflammation function	evaluate monocyte / lymphocyte ratio (MLR) before operation	three days before surgery
postoperative inflammation function	evaluate systemic immune inflammation index (SII) after operation	three days after surgery
postoperative inflammation function	evaluate neutrophil / lymphocyte ratio (NLR) after operation	three days after surgery
postoperative inflammation function	evaluate platelet / lymphocyte ratio (PLR) after operation	three days after surgery
postoperative inflammation function	evaluate monocyte / lymphocyte ratio (MLR) after operation	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale(VAS) score after surgery	evaluate VAS (0-10 points)score 24 hours after surgery	24 hours after surgery
postoperative adverse effects	evaluate postoperative adverse effect 24 hours after surgery	24 hours after surgery

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 20, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (ACTUAL): September 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Sex, cognition, inflammation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No