Sex Differences in Postoperative Sleep Quality and Inflammation

• Sponsor: Shengjing Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04608435
• Collaborator: (none)
• Enrollment: 213
• Location: 1
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sex Differences; Postoperative Sleep Quality; Postoperative Pain; Inflammation Function	Other: Video-Assisted Thoracoscopic Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 213 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery
• Actual Study Start Date: Oct 31, 2020
• Actual Primary Completion Date: Feb 20, 2022
• Actual Study Completion Date: Feb 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Male Group	Other: Video-Assisted Thoracoscopic Surgery; patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
Female Group	Other: Video-Assisted Thoracoscopic Surgery; patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Outcome Measures

Primary Outcome Measures

1. sleep quality of one night before surgery [first night before surgery]

   Use Athens insomnia scale to test the sleep quality the first night before surgery

2. sleep quality of first night after surgery [first night after surgery]

   Use Athens insomnia scale to test the sleep quality the first night after surgery

3. sleep quality of third night after surgery [third night after surgery]

   Use Athens insomnia scale to test the sleep quality the third night after surgery

Secondary Outcome Measures

1. visual analog scale(VAS) score after surgery [one day before surgery]

   evaluate VAS score after surgery

2. visual analog scale(VAS) score after surgery [3 hours after surgery]

   evaluate VAS score after surgery

3. visual analog scale(VAS) score after surgery [8 pm the first day after surgery]

   evaluate VAS score after surgery

4. postoperative adverse effect [24 hours after surgery]

   evaluate postoperative adverse effect 24 hours after surgery

5. perioperative inflammation function [two days before surgery]

   evaluate neutrophils

6. perioperative inflammation function [two days before surgery]

   evaluate platelet

7. perioperative inflammation function [two days before surgery]

   evaluate lymphocyte

8. perioperative inflammation function [first days after surgery]

   evaluate neutrophils,platelet,lymphocyte

9. perioperative inflammation function [first days after surgery]

   evaluate neutrophils

10. perioperative inflammation function [first days after surgery]

    evaluate platelet

11. perioperative inflammation function [first days after surgery]

    evaluate lymphocyte

12. Postoperative cognition evaluation [one day before surgery]

    Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.

13. Postoperative cognition evaluation [first day after surgery]

    Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.

14. Postoperative cognition evaluation [third day after surgery]

    Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shengjing Hospital	Shenyang	Liaoning	China	110004

Sponsors and Collaborators

• Shengjing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanchao Yang, principal investigator, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT04608435
• Other Study ID Numbers: Sex, sleep and inflammation
• First Posted: Oct 29, 2020
• Last Update Posted: May 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yanchao Yang, principal investigator, Shengjing Hospital: sex differences; postoperative sleep quality; postoperative pain; inflammation function
• Additional relevant MeSH terms: Inflammation; Pain, Postoperative

Study Results

No Results Posted as of May 4, 2022