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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05059548
Other study ID # Sex, cognition, inflammation
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2021
Est. completion date December 31, 2021

Study information

Verified date September 2021
Source Shengjing Hospital
Contact junchao zhu
Phone +8618940257257
Email zhujunchao1@hotmail.com
Is FDA regulated No
Health authority
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, sleep quality and cognitive function among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.


Recruitment information / eligibility

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;

Study Design


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 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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