NCT04608435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 31, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

October 23, 2020

Last Update Submit

April 28, 2022

Conditions

Sex DifferencesPostoperative Sleep QualityPostoperative PainInflammation Function

Keywords

sex differencespostoperative sleep qualitypostoperative paininflammation function

Outcome Measures

Primary Outcomes (3)

  • sleep quality of one 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

    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

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

    third night after surgery

Secondary Outcomes (14)

  • visual analog scale(VAS) score after surgery

    one day before surgery

  • visual analog scale(VAS) score after surgery

    3 hours after surgery

  • visual analog scale(VAS) score after surgery

    8 pm the first day after surgery

  • postoperative adverse effect

    24 hours after surgery

  • perioperative inflammation function

    two days before surgery

  • +9 more secondary outcomes

Study Arms (2)

Male Group

Other: Video-Assisted Thoracoscopic Surgery

Female Group

Other: Video-Assisted Thoracoscopic Surgery

Interventions

Video-Assisted Thoracoscopic SurgeryOTHER

patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Female GroupMale Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing video-assisted thoracoscopic surgery under general anesthesia

You may qualify if:

  • years old
  • ASA I-III
  • under general anesthesia

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 29, 2020

Study Start

October 31, 2020

Primary Completion

February 20, 2022

Study Completion

February 27, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)