Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 6:20 AM
Study NCT ID:
NCT04981093
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone on Postoperative Inflammatory Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of drainage fluid volume', 'timeFrame': '6 hours after surgery， the morning of 1, 2, and 3 days after surgery', 'description': 'Drainage fluid （ml）was collected and the volume of drainage fluid was recorded\n\nUntil the drainage tube was pulled out,'}, {'measure': 'the change of Inflammatory mediators in the drainage fluid', 'timeFrame': '6 hours after surgery， the morning of 1, 2, and 3 days after surgery', 'description': 'CRP(mg/ L) in postoperative drainage fluid was observed'}], 'secondaryOutcomes': [{'measure': 'the change of blood inflammatory mediators', 'timeFrame': '6 hours after surgery， the morning of 1, 2, and 3 days after surgery', 'description': 'Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery\n\nFasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique\n\nAfter the blood CRP(mg/l)'}, {'measure': 'the change of blood routine white blood cell count', 'timeFrame': '6 hours after surgery， the morning of 1, 2, and 3 days after surgery', 'description': 'Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery\n\nFasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique\n\nAfter the blood blood routine white blood cell count'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intravenous dexamethasone', 'inflammation', 'QoR15', 'drainage'], 'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '31494615', 'type': 'BACKGROUND', 'citation': "Corcoran TB, Myles PS, Forbes AB, O'Loughlin E, Leslie K, Story D, Short TG, Chan MT, Coutts P, Sidhu J, Cheng AC, Bach LA, Ho KM; Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network. The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study. BMJ Open. 2019 Sep 6;9(9):e030402. doi: 10.1136/bmjopen-2019-030402."}, {'pmid': '33951362', 'type': 'BACKGROUND', 'citation': "Corcoran TB, Myles PS, Forbes AB, Cheng AC, Bach LA, O'Loughlin E, Leslie K, Chan MTV, Story D, Short TG, Martin C, Coutts P, Ho KM; PADDI Investigators; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Australasian Society for Infectious Diseases Clinical Research Network. Dexamethasone and Surgical-Site Infection. N Engl J Med. 2021 May 6;384(18):1731-1741. doi: 10.1056/NEJMoa2028982."}]}, 'descriptionModule': {'briefSummary': 'This topic foe randomized prospective study.Detection of elderly patients with lunmbar spinal postoperative inflammatory substances in the blood and drainage of liquid level ,clear whether low-dose dexamethasone can inhibit the inflammation, the observation of elderly patients with lumbar spinal postoperative drainage star, to explor whether low-dose dexamthasone can reduce postoperative incision drainage, thus impove the postoprative drainage tube pull rate within three days, which in turn reduce because of the place a retrograde infection caused by drainage tube.', 'detailedDescription': 'A total of 100 patients undergoing posterior lumbar disc fusion were randomly divided into control group (group C,n=50) and dexamethasone group (group D,n=50). Group D was given 0.15mg/kg dexamethasone (2ml) intravenously after anesthesia induction. Group C was also intravenously injected with 2ml normal saline after anesthesia induction.On this basis, monitor the main results and secondary results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥65years of age\n* American Society of Anesthesiologists (ASA) physical status 2-4\n* Elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia\n* Requiring a hospital stay of at least one postoperative night\n* A surgical skin incision \\>5 cm in length or multiple incisions with a total incision length of \\>5 cm\n\nExclusion Criteria:·\n\n* Poorly controlled diabetes (HbA1c\\>9.0%)\n* Endovascular procedure with a small (\\<5 cm length) skin incision Ophthalmic surgery\n* Planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)\n* Recent (\\<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics\n* Chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)'}, 'identificationModule': {'nctId': 'NCT04981093', 'briefTitle': 'Effect of Dexamethasone on Postoperative Inflammatory Factors', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery', 'orgStudyIdInfo': {'id': '2020-519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Dexamethasone', 'description': 'Group dexamethasone patients received intravenous injection after anesthesia induction\n\nInjection 0.15mg/kg dexamethasone (2ml）', 'interventionNames': ['Drug: Dexamethasone Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group Saline', 'description': 'Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Dexamethasone Injection', 'type': 'DRUG', 'description': 'Intravenous injection after induction of anesthesia\n\nInjection 0.15mg/kg dexamethasone (2ml)', 'armGroupLabels': ['Group Dexamethasone']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '2ml of normal saline was injected intravenously after induction of anesthesia', 'armGroupLabels': ['Group Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}