Clinical trial NCT05059548: Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia
Official title: Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sex Differences
Postoperative Sleep Quality
Postoperative Pain
Inflammation Function
Postoperative Cognitive Function
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 100
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, sleep quality and cognitive function among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.


Eligibility criteria: 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;

Primary outcomes:
measure: sleep quality of one night before surgery
timeFrame: one 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
measure: preoperative inflammation function
timeFrame: three days before surgery
measure: preoperative inflammation function
timeFrame: three days before surgery
measure: preoperative inflammation function
timeFrame: three days before surgery
measure: preoperative inflammation function
timeFrame: three days before surgery
measure: postoperative inflammation function
timeFrame: three days after surgery
measure: postoperative inflammation function
timeFrame: three days after surgery
measure: postoperative inflammation function
timeFrame: three days after surgery
measure: postoperative inflammation function
timeFrame: three days after surgery
measure: neuropsychological test
timeFrame: 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 outcomes:
measure: visual analog scale(VAS) score after surgery
timeFrame: 24 hours after surgery
measure: postoperative adverse effects
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: junchao zhu
role: STUDY_DIRECTOR
References: