Sex Differences in Postoperative Sleep Quality and Inflammation

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Postoperative Sleep Quality; Sex Differences; Inflammation Function
• Intervention / Treatment: Other: Video-Assisted Thoracoscopic Surgery

• Study Type: Observational
• Enrollment (Actual): 213

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:

• 18-80 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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male Group	Other: Video-Assisted Thoracoscopic Surgery; patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
Female Group	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 Athens insomnia scale to test the sleep quality the first night before surgery	first night before surgery
sleep quality of first night after surgery	Use Athens insomnia scale to test the sleep quality the first night after surgery	first night after surgery
sleep quality of third night after surgery	Use Athens insomnia scale to test the sleep quality the third night after surgery	third night after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale(VAS) score after surgery	evaluate VAS score after surgery	one day before surgery
visual analog scale(VAS) score after surgery	evaluate VAS score after surgery	3 hours after surgery
visual analog scale(VAS) score after surgery	evaluate VAS score after surgery	8 pm the first day after surgery
postoperative adverse effect	evaluate postoperative adverse effect 24 hours after surgery	24 hours after surgery
perioperative inflammation function	evaluate neutrophils	two days before surgery
perioperative inflammation function	evaluate platelet	two days before surgery
perioperative inflammation function	evaluate lymphocyte	two days before surgery
perioperative inflammation function	evaluate neutrophils,platelet,lymphocyte	first days after surgery
perioperative inflammation function	evaluate neutrophils	first days after surgery
perioperative inflammation function	evaluate platelet	first days after surgery
perioperative inflammation function	evaluate lymphocyte	first days after surgery
Postoperative cognition evaluation	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.	one day before surgery
Postoperative cognition evaluation	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.	first day after surgery
Postoperative cognition evaluation	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.	third day after surgery

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2020
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): February 27, 2022

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: sex differences; postoperative pain; postoperative sleep quality; inflammation function
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Inflammation
• Other Study ID Numbers: Sex, sleep and inflammation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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