Sex Differences in Postoperative Sleep Quality and Inflammation

Completed

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

• Registration Number: NCT04608435
• 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 and sleep quality among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-29
• Study Start: 2020-10-31
• Primary Completion: 2022-02-20
• Study Completion: 2022-02-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male Group	Video-Assisted Thoracoscopic Surgery	-
Female Group	Video-Assisted Thoracoscopic Surgery	-

Primary Outcome Measures

Name	Time	Method
sleep quality of first night after surgery	first night after surgery	Use Athens insomnia scale to test the sleep quality the first night after surgery
sleep quality of one night before surgery	first night before surgery	Use Athens insomnia scale to test the sleep quality the first night before surgery
sleep quality of third night after surgery	third night after surgery	Use Athens insomnia scale to test the sleep quality the third night after surgery

Secondary Outcome Measures

Name	Time	Method
perioperative inflammation function	first days after surgery	evaluate lymphocyte
visual analog scale(VAS) score after surgery	8 pm the first day after surgery	evaluate VAS score after surgery
postoperative adverse effect	24 hours after surgery	evaluate postoperative adverse effect 24 hours after surgery
Postoperative cognition evaluation	third day after surgery	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.

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China