Sex Differences in Postoperative Sleep Quality and Inflammation

April 28, 2022 updated by: Yanchao Yang, Shengjing Hospital

Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing video-assisted thoracoscopic surgery under general anesthesia

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sleep quality of one night before surgery
Time Frame: first night before surgery
Use Athens insomnia scale to test the sleep quality the first night before surgery
first night before surgery
sleep quality of first night after surgery
Time Frame: first night after surgery
Use Athens insomnia scale to test the sleep quality the first night after surgery
first night after surgery
sleep quality of third night after surgery
Time Frame: third night after surgery
Use Athens insomnia scale to test the sleep quality the third night after surgery
third night after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
visual analog scale(VAS) score after surgery
Time Frame: one day before surgery
evaluate VAS score after surgery
one day before surgery
visual analog scale(VAS) score after surgery
Time Frame: 3 hours after surgery
evaluate VAS score after surgery
3 hours after surgery
visual analog scale(VAS) score after surgery
Time Frame: 8 pm the first day after surgery
evaluate VAS score after surgery
8 pm the first day after surgery
postoperative adverse effect
Time Frame: 24 hours after surgery
evaluate postoperative adverse effect 24 hours after surgery
24 hours after surgery
perioperative inflammation function
Time Frame: two days before surgery
evaluate neutrophils
two days before surgery
perioperative inflammation function
Time Frame: two days before surgery
evaluate platelet
two days before surgery
perioperative inflammation function
Time Frame: two days before surgery
evaluate lymphocyte
two days before surgery
perioperative inflammation function
Time Frame: first days after surgery
evaluate neutrophils,platelet,lymphocyte
first days after surgery
perioperative inflammation function
Time Frame: first days after surgery
evaluate neutrophils
first days after surgery
perioperative inflammation function
Time Frame: first days after surgery
evaluate platelet
first days after surgery
perioperative inflammation function
Time Frame: first days after surgery
evaluate lymphocyte
first days after surgery
Postoperative cognition evaluation
Time Frame: 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.
one day before surgery
Postoperative cognition evaluation
Time Frame: 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.
first day after surgery
Postoperative cognition evaluation
Time Frame: 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.
third day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sex, sleep and inflammation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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