Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-31 @ 10:21 AM
Study NCT ID:
NCT05201560
Status:
UNKNOWN
Last Update Posted:
2022-01-21
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002077', 'term': 'Butorphanol'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hospital-acquired infections', 'timeFrame': 'one month', 'description': 'Incidence of hospital-acquired infections'}], 'secondaryOutcomes': [{'measure': 'duration on ventilators', 'timeFrame': 'one month', 'description': 'patients enrolled will be followed for the duration of mechanical ventilation'}, {'measure': 'ICU stay', 'timeFrame': 'one month', 'description': 'patients enrolled will be followed for length of ICU stay'}, {'measure': 'Hospital stay', 'timeFrame': 'one month', 'description': 'patients enrolled will be followed for length of Hospital stay'}, {'measure': 'all cause mortality', 'timeFrame': 'one month', 'description': 'all cause mortality'}, {'measure': 'Blood routine examination is assessed by the white blood cell count', 'timeFrame': 'on the 1st, 3rd，7th day after enrollment'}, {'measure': 'Blood routine examination is assessed by neutrophil count.', 'timeFrame': 'on the 1st, 3rd，7th day after enrollment'}, {'measure': 'Cytokines', 'timeFrame': 'on the 1st, 3rd，7th day after enrollment', 'description': 'Cytokines are assessed by the interleukin-1,interleukin-6 and interleukin-10'}, {'measure': 'adverse events', 'timeFrame': 'one month', 'description': 'Nausea, vomiting, dry mouth, bradycardia, hypotension, respiratory depression and other adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Hospital-acquired Infections']}, 'referencesModule': {'references': [{'pmid': '9187957', 'type': 'RESULT', 'citation': 'Fridkin SK, Welbel SF, Weinstein RA. Magnitude and prevention of nosocomial infections in the intensive care unit. Infect Dis Clin North Am. 1997 Jun;11(2):479-96. doi: 10.1016/s0891-5520(05)70366-4.'}, {'pmid': '19952319', 'type': 'RESULT', 'citation': 'Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.'}, {'pmid': '12626983', 'type': 'RESULT', 'citation': 'Meissner W, Dohrn B, Reinhart K. Enteral naloxone reduces gastric tube reflux and frequency of pneumonia in critical care patients during opioid analgesia. Crit Care Med. 2003 Mar;31(3):776-80. doi: 10.1097/01.CCM.0000053652.80849.9F.'}, {'pmid': '30113379', 'type': 'RESULT', 'citation': 'Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.'}, {'pmid': '17625779', 'type': 'RESULT', 'citation': 'Giamberardino HI, Cesario EP, Carmes ER, Mulinari RA. Risk factors for nosocomial infection in trauma patients. Braz J Infect Dis. 2007 Apr;11(2):285-9. doi: 10.1590/s1413-86702007000200024.'}, {'pmid': '30989063', 'type': 'RESULT', 'citation': 'Baviskar AS, Khatib KI, Rajpal D, Dongare HC. Nosocomial infections in surgical intensive care unit: A retrospective single-center study. Int J Crit Illn Inj Sci. 2019 Jan-Mar;9(1):16-20. doi: 10.4103/IJCIIS.IJCIIS_57_18.'}, {'pmid': '17505683', 'type': 'RESULT', 'citation': 'Aguilar-Nascimento JE, Marra JG, Slhessarenko N, Fontes CJ. Efficacy of National Nosocomial Infection Surveillance score, acute-phase proteins, and interleukin-6 for predicting postoperative infections following major gastrointestinal surgery. Sao Paulo Med J. 2007 Jan 4;125(1):34-41. doi: 10.1590/s1516-31802007000100007.'}]}, 'descriptionModule': {'briefSummary': 'To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.', 'detailedDescription': 'Butorphanol can improve inflammation and promote the recovery of pro-inflammatory/anti-inflammatory cytokine balance.However, there is still a lack of relevant clinical studies on butorphanol and fentanyl for the incidence of hospital-acquired infections in ICU mechanically ventilated patients.The objective of this study was to evaluate the analgesic efficacy,safety and the incidence of nosocomial infection of butorphanol in mechanical ventilation patients between butorphanol and fentanyl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* need mechanical ventilation for more than 48 hours\n* more than 18 years old\n* without hospital-acquired infection before admission to ICU\n* volunteer to participate in this study\n\nExclusion Criteria:\n\n* allergic or contraindicated to the drug\n* severe cardiac insufficiency, conduction block and bradycardia\n* recent use of analgesic, sedative and antidepressant drugs\n* psychiatric or neurological diseases or neurosurgery-related diseases\n* history of steroid cortisol and immunosuppressants\n* severe liver dysfunction or renal dysfunction\n* pregnancy\n* refuse to enrollment'}, 'identificationModule': {'nctId': 'NCT05201560', 'briefTitle': 'Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation:a Randomized and Controlled Trial', 'orgStudyIdInfo': {'id': 'SICU-20211026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Butorphanol tartrate', 'description': 'Butorphanol tartrate on the patients with mechanical ventilation', 'interventionNames': ['Drug: Butorphanol Tartrate Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl', 'description': 'fentanyl on the patients with mechanical ventilation', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Butorphanol Tartrate Injection', 'type': 'DRUG', 'otherNames': ['the drug of butorphanol tartrate'], 'description': 'Patients of this group will receive Butorphanol Tartrate Injection', 'armGroupLabels': ['Butorphanol tartrate']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['the drug of fentanyl'], 'description': 'Patients of this group will receive Fentanyl', 'armGroupLabels': ['fentanyl']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Wu', 'role': 'CONTACT', 'email': 'wu.wei@zs-hospital.sh.cn', 'phone': '13817976707'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}