Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia

Postoperative Pain Clinical Trial

Official title:

Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05059548
• Other study ID #: Sex, cognition, inflammation
• Status: Not yet recruiting
• 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
• 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;

Related Conditions & MeSH terms

• Inflammation
• Postoperative Cognitive Function
• 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 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