Clinical trial NCT04608435: Sex Differences in Postoperative Sleep Quality and Inflammation
Official title: Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sex Differences
Postoperative Sleep Quality
Postoperative Pain
Inflammation Function
Keywords: sex differences
postoperative sleep quality
postoperative pain
inflammation function
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing video-assisted thoracoscopic surgery under general anesthesia

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.


Eligibility criteria: 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;

Primary outcomes:
measure: sleep quality of one night before surgery
timeFrame: first night before surgery
measure: sleep quality of first night after surgery
timeFrame: first night after surgery
measure: sleep quality of third night after surgery
timeFrame: third night after surgery
Secondary outcomes:
measure: visual analog scale(VAS) score after surgery
timeFrame: one day before surgery
measure: visual analog scale(VAS) score after surgery
timeFrame: 3 hours after surgery
measure: visual analog scale(VAS) score after surgery
timeFrame: 8 pm the first day after surgery
measure: postoperative adverse effect
timeFrame: 24 hours after surgery
measure: perioperative inflammation function
timeFrame: two days before surgery
measure: perioperative inflammation function
timeFrame: two days before surgery
measure: perioperative inflammation function
timeFrame: two days before surgery
measure: perioperative inflammation function
timeFrame: first days after surgery
measure: perioperative inflammation function
timeFrame: first days after surgery
measure: perioperative inflammation function
timeFrame: first days after surgery
measure: perioperative inflammation function
timeFrame: first days after surgery
measure: Postoperative cognition evaluation
timeFrame: one day before surgery
measure: Postoperative cognition evaluation
timeFrame: first day after surgery
measure: Postoperative cognition evaluation
timeFrame: third day after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
References: