Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 12:48 PM
Study NCT ID:
NCT04608435
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex Differences in Postoperative Sleep Quality and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep quality of one night before surgery', 'timeFrame': 'first night before surgery', 'description': 'Use Athens insomnia scale to test the sleep quality the first night before surgery'}, {'measure': 'sleep quality of first night after surgery', 'timeFrame': 'first night after surgery', 'description': 'Use Athens insomnia scale to test the sleep quality the first night after surgery'}, {'measure': 'sleep quality of third night after surgery', 'timeFrame': 'third night after surgery', 'description': 'Use Athens insomnia scale to test the sleep quality the third night after surgery'}], 'secondaryOutcomes': [{'measure': 'visual analog scale(VAS) score after surgery', 'timeFrame': 'one day before surgery', 'description': 'evaluate VAS score after surgery'}, {'measure': 'visual analog scale(VAS) score after surgery', 'timeFrame': '3 hours after surgery', 'description': 'evaluate VAS score after surgery'}, {'measure': 'visual analog scale(VAS) score after surgery', 'timeFrame': '8 pm the first day after surgery', 'description': 'evaluate VAS score after surgery'}, {'measure': 'postoperative adverse effect', 'timeFrame': '24 hours after surgery', 'description': 'evaluate postoperative adverse effect 24 hours after surgery'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'two days before surgery', 'description': 'evaluate neutrophils'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'two days before surgery', 'description': 'evaluate platelet'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'two days before surgery', 'description': 'evaluate lymphocyte'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'first days after surgery', 'description': 'evaluate neutrophils,platelet,lymphocyte'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'first days after surgery', 'description': 'evaluate neutrophils'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'first days after surgery', 'description': 'evaluate platelet'}, {'measure': 'perioperative inflammation function', 'timeFrame': 'first days after surgery', 'description': 'evaluate lymphocyte'}, {'measure': 'Postoperative cognition evaluation', 'timeFrame': 'one day before surgery', 'description': '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.'}, {'measure': 'Postoperative cognition evaluation', 'timeFrame': 'first day after surgery', 'description': '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.'}, {'measure': 'Postoperative cognition evaluation', 'timeFrame': 'third day after surgery', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sex differences', 'postoperative sleep quality', 'postoperative pain', 'inflammation function'], 'conditions': ['Sex Differences', 'Postoperative Sleep Quality', 'Postoperative Pain', 'Inflammation Function']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing video-assisted thoracoscopic surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* ASA I-III\n* under general anesthesia\n\nExclusion Criteria:\n\n* patients with central nervous system and mental diseases;\n* patients with preoperative sleep disturbances;\n* patients with a history of sedative, analgesic, or antidepression drug use;\n* patients with sleep apnea or moderate and severe obstructive sleep apnea-hypopnea syndrome;'}, 'identificationModule': {'nctId': 'NCT04608435', 'briefTitle': 'Sex Differences in Postoperative Sleep Quality and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': 'Sex, sleep and inflammation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male Group', 'interventionNames': ['Other: Video-Assisted Thoracoscopic Surgery']}, {'label': 'Female Group', 'interventionNames': ['Other: Video-Assisted Thoracoscopic Surgery']}], 'interventions': [{'name': 'Video-Assisted Thoracoscopic Surgery', 'type': 'OTHER', 'description': 'patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia', 'armGroupLabels': ['Female Group', 'Male Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Yanchao Yang', 'investigatorAffiliation': 'Shengjing Hospital'}}}}