Postoperative Pain Clinical Trial
Official title:
Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
China | Shengjing Hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shengjing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sleep quality of one night before surgery | use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with = 6 points indicating a diagnosis of insomnia) | one night before surgery | |
Primary | sleep quality of first night after surgery | use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with = 6 points indicating a diagnosis of insomnia) | first night after surgery | |
Primary | sleep quality of third night after surgery | use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with = 6 points indicating a diagnosis of insomnia) | third night after surgery | |
Primary | preoperative inflammation function | evaluate systemic immune inflammation index (SII) before operation | three days before surgery | |
Primary | preoperative inflammation function | evaluate neutrophil / lymphocyte ratio (NLR)before operation | three days before surgery | |
Primary | preoperative inflammation function | evaluate platelet / lymphocyte ratio (PLR) before operation | three days before surgery | |
Primary | preoperative inflammation function | evaluate monocyte / lymphocyte ratio (MLR) before operation | three days before surgery | |
Primary | postoperative inflammation function | evaluate systemic immune inflammation index (SII) after operation | three days after surgery | |
Primary | postoperative inflammation function | evaluate neutrophil / lymphocyte ratio (NLR) after operation | three days after surgery | |
Primary | postoperative inflammation function | evaluate platelet / lymphocyte ratio (PLR) after operation | three days after surgery | |
Primary | postoperative inflammation function | evaluate monocyte / lymphocyte ratio (MLR) after operation | three days after surgery | |
Primary | neuropsychological test | The neuropsychological test battery included the tests used to evaluate patients for delayed neurocognitive recovery in the International Study of Post-Operative Cognitive Dysfunction: (1) word learning: visual verbal learning test based on the Rey's auditory recall of words; (2) word recall: the number or words recalled from visual verbal learning trials after a 20-min delay; (3) cognitive flexibility: including trail making test A and B; (4) distractibility: Stroop color word interference test; and (5) working memory: letter-digit coding. If a patient exhibited delirium at a testing time, neuropsychological evaluation was postponed 3 days. | 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 | visual analog scale(VAS) score after surgery | evaluate VAS (0-10 points)score 24 hours after surgery | 24 hours after surgery | |
Secondary | postoperative adverse effects | evaluate postoperative adverse effect 24 hours after surgery | 24 hours after surgery |
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