Sex Differences in Postoperative Sleep Quality and Inflammation

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608435
• Other study ID #: Sex, sleep and inflammation
• Status: Completed
• Start date: October 31, 2020
• Est. completion date: February 27, 2022

Study information

• Verified date: April 2022
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: February 27, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Postoperative Pain
• Postoperative Sleep Quality
• Sex Differences

Intervention

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

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	visual analog scale(VAS) score after surgery	evaluate VAS score after surgery	one day before surgery
Secondary	visual analog scale(VAS) score after surgery	evaluate VAS score after surgery	3 hours after surgery
Secondary	visual analog scale(VAS) score after surgery	evaluate VAS score after surgery	8 pm the first day after surgery
Secondary	postoperative adverse effect	evaluate postoperative adverse effect 24 hours after surgery	24 hours after surgery
Secondary	perioperative inflammation function	evaluate neutrophils	two days before surgery
Secondary	perioperative inflammation function	evaluate platelet	two days before surgery
Secondary	perioperative inflammation function	evaluate lymphocyte	two days before surgery
Secondary	perioperative inflammation function	evaluate neutrophils,platelet,lymphocyte	first days after surgery
Secondary	perioperative inflammation function	evaluate neutrophils	first days after surgery
Secondary	perioperative inflammation function	evaluate platelet	first days after surgery
Secondary	perioperative inflammation function	evaluate lymphocyte	first days after surgery
Secondary	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
Secondary	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
Secondary	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