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Sex Differences in Postoperative Sleep Quality and Inflammation

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ClinicalTrials.gov Identifier: NCT04608435
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Yanchao Yang, Shengjing Hospital

Study Description
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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
Sex Differences Postoperative Sleep Quality Postoperative Pain Inflammation Function Other: Video-Assisted Thoracoscopic Surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 80 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 : October 31, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. sleep quality of one night before surgery [ Time Frame: first night before surgery ]
    Use portable sleep monitor to test the sleep quality the first night before surgery

  2. sleep quality of first night after surgery [ Time Frame: first night after surgery ]
    Use portable sleep monitor to test the sleep quality the first night after surgery

  3. sleep quality of third night after surgery [ Time Frame: third night after surgery ]
    Use portable sleep monitor to test the sleep quality the third night after surgery


Secondary Outcome Measures :
  1. visual analog scale(VAS) score after surgery [ Time Frame: 24 hours after surgery ]
    evaluate VAS score 24 hours after surgery

  2. postoperative adverse effect [ Time Frame: 24 hours after surgery ]
    evaluate postoperative adverse effect 24 hours after surgery

  3. perioperative inflammation function [ Time Frame: three days before surgery ]
    evaluate C-reactive protein (CRP)

  4. perioperative inflammation function [ Time Frame: three days before surgery ]
    evaluate neutrophils

  5. perioperative inflammation function [ Time Frame: three days before surgery ]
    evaluate platelet

  6. perioperative inflammation function [ Time Frame: three days before surgery ]
    evaluate lymphocyte

  7. perioperative inflammation function [ Time Frame: three days after surgery ]
    evaluate C-reactive protein (CRP),neutrophils,platelet,lymphocyte

  8. perioperative inflammation function [ Time Frame: three days after surgery ]
    evaluate C-reactive protein (CRP)

  9. perioperative inflammation function [ Time Frame: three days after surgery ]
    evaluate neutrophils

  10. perioperative inflammation function [ Time Frame: three days after surgery ]
    evaluate platelet

  11. perioperative inflammation function [ Time Frame: three days after surgery ]
    evaluate lymphocyte


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing video-assisted thoracoscopic surgery under general anesthesia
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608435


Contacts
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Contact: Junchao Zhu 18940257257 zhujunchao1@hotmail.com

Locations
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China, Liaoning
Shengjing Hospital Recruiting
Shenyang, Liaoning, China, 110004
Contact: junchao zhu    +8618940257257    zhujunchao1@hotmail.com   
Sponsors and Collaborators
Shengjing Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yanchao Yang, principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT04608435    
Other Study ID Numbers: Sex, sleep and inflammation
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanchao Yang, Shengjing Hospital:
sex differences
postoperative sleep quality
postoperative pain
inflammation function
Additional relevant MeSH terms:
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Inflammation
Pain, Postoperative
Pathologic Processes
 Postoperative Complications
Pain
Neurologic Manifestations