Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04734418
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2021-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-14', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.', 'timeFrame': 'Within 72 hours of study drug used'}], 'secondaryOutcomes': [{'measure': 'Mortality in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}, {'measure': 'Mechanical ventilation time in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}, {'measure': 'Hemodynamic changes in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}, {'measure': 'Incidence of delirium in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}, {'measure': 'Days in ICU in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}, {'measure': 'Intubation rate in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}, {'measure': 'Tracheotomy rate in both remifentanil and dexmedetomidine group', 'timeFrame': 'Up to 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NIV Intolerance']}, 'referencesModule': {'references': [{'pmid': '33209418', 'type': 'RESULT', 'citation': 'Hao GW, Luo JC, Xue Y, Ma GG, Su Y, Hou JY, Yu SJ, Liu K, Zheng JL, Tu GW, Luo Z. Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study. J Thorac Dis. 2020 Oct;12(10):5857-5868. doi: 10.21037/jtd-20-1678.'}, {'pmid': '39294818', 'type': 'DERIVED', 'citation': 'Hao GW, Wu JQ, Yu SJ, Liu K, Xue Y, Gong Q, Xie RC, Ma GG, Su Y, Hou JY, Zhang YJ, Liu WJ, Li W, Tu GW, Luo Z. Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial. J Intensive Care. 2024 Sep 18;12(1):35. doi: 10.1186/s40560-024-00750-2.'}, {'pmid': '37189085', 'type': 'DERIVED', 'citation': 'Deng YZ, Luo MH, Luo JC, Li JK, Chen JQ, Zhang YJ, Hou JY, Su Y, Tu GW, Luo Z. Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD): study protocol for a prospective, single-center, randomized controlled trial. BMC Anesthesiol. 2023 May 15;23(1):164. doi: 10.1186/s12871-023-02124-x.'}, {'pmid': '35345251', 'type': 'DERIVED', 'citation': 'Luo MH, Hao GW, Liu K, Yin K, Yu SJ, Wang H, Su Y, Luo JC, Wei YQ, Wang YH, Pan WQ, Tu GW, Luo Z. Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial. Rev Cardiovasc Med. 2022 Mar 4;23(3):84. doi: 10.31083/j.rcm2303084.'}], 'seeAlsoLinks': [{'url': 'https://jtd.amegroups.com/article/view/44501/html', 'label': 'Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study'}]}, 'descriptionModule': {'briefSummary': "Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign the informed consent form voluntarily and follow the plan requirements;\n* Age from 18 to 75 years old (including 18 and 75 years old), regardless of gender;\n* Patients who received non-invasive mechanical ventilation after cardiac surgery and were intolerant of non-invasive ventilation.\n\nExclusion Criteria:\n\n* A history of allergy to any component of the study drug;\n* Visual analogue scale of pain (VAS) score \\>4；\n* Who had taken dexmedetomidine within 8 hours prior to the study;\n* Who had used remifentanil within 2 hours before the study began;\n* Expectoration difficulties;\n* Women who are pregnant or lactating;\n* Coma or uncontrollable convulsions;\n* Have a history of mental illness or cognitive impairment;\n* Delirium before the study began;\n* Patients with severe liver dysfunction (CTP grade C);\n* Patients with renal insufficiency (patients receiving renal replacement therapy);\n* Preoperative left ventricular ejection fraction (LVEF) \\< 30%;\n* History of drug and alcohol abuse;\n* Other conditions that the investigator deems inappropriate for participation in this clinical trial.'}, 'identificationModule': {'nctId': 'NCT04734418', 'briefTitle': 'Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance After Cardiac Surgery: a Multicenter, Prospective, Single-blind, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'REDNIVI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remifentanil group', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': "Intravenous pump injection.The initial dose of remifentanil is 0.05 μg/kg/min.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of remifentanil is 0.12 μg/kg/min", 'armGroupLabels': ['Remifentanil group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': "Intravenous pump injection.The initial dose of dexmedetomidine is 0.5 μg/kg/h.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of dexmedetomidine is 1.0 μg/kg/h.", 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-wei Tu, Doctor', 'role': 'CONTACT', 'email': 'tu.guowei@zs-hospital.sh.cn', 'phone': '86-13501996995'}, {'name': 'Guo-wei Tu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guo-wei Tu, MD PhD', 'role': 'CONTACT', 'email': 'tu.guowei@zs-hospital.sh.cn', 'phone': '13501996995'}, {'name': 'Guang-wei Hao, MD PhD', 'role': 'CONTACT', 'email': 'hao.guangwei@zs-hospital.sh.cn', 'phone': '15921488129'}], 'overallOfficials': [{'name': 'Zhe Luo, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Guowei Tu', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}