Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT06366412
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours', 'timeFrame': '2 years', 'description': 'Heart Rate will be measured in beat/min'}, {'measure': 'Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours', 'timeFrame': '2 years', 'description': 'Mean Arterial Blood Pressure will be measured in mmHg/min'}], 'primaryOutcomes': [{'measure': 'the effect of dexmedetomidine on serum Tau-217 protein value.', 'timeFrame': '2 years', 'description': 'estimation of the effect of dexmedetomidine on serum Tau-217 protein in postoperative period.'}], 'secondaryOutcomes': [{'measure': 'to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group.', 'timeFrame': '2 years', 'description': 'evaluation of the postoperative cognitive dysfunction by Mini Mental State Scale as \\>25 is recorded normal while less than \\<24 is positive for cognitive dysfunction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'serum Tau-217 protein', 'cognitive dysfunction'], 'conditions': ['Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '34418401', 'type': 'BACKGROUND', 'citation': "Thijssen EH, La Joie R, Strom A, Fonseca C, Iaccarino L, Wolf A, Spina S, Allen IE, Cobigo Y, Heuer H, VandeVrede L, Proctor NK, Lago AL, Baker S, Sivasankaran R, Kieloch A, Kinhikar A, Yu L, Valentin MA, Jeromin A, Zetterberg H, Hansson O, Mattsson-Carlgren N, Graham D, Blennow K, Kramer JH, Grinberg LT, Seeley WW, Rosen H, Boeve BF, Miller BL, Teunissen CE, Rabinovici GD, Rojas JC, Dage JL, Boxer AL; Advancing Research and Treatment for Frontotemporal Lobar Degeneration investigators. Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer's disease and frontotemporal lobar degeneration: a retrospective diagnostic performance study. Lancet Neurol. 2021 Sep;20(9):739-752. doi: 10.1016/S1474-4422(21)00214-3."}, {'pmid': '35465951', 'type': 'BACKGROUND', 'citation': 'McKay TB, Qu J, Liang F, Mueller A, Wiener-Kronish J, Xie Z, Akeju O. Tau as a serum biomarker of delirium after major cardiac surgery: a single centre case-control study. Br J Anaesth. 2022 Jul;129(1):e13-e16. doi: 10.1016/j.bja.2022.04.002. Epub 2022 Apr 22. No abstract available.'}, {'pmid': '33228978', 'type': 'BACKGROUND', 'citation': 'Ballweg T, White M, Parker M, Casey C, Bo A, Farahbakhsh Z, Kayser A, Blair A, Lindroth H, Pearce RA, Blennow K, Zetterberg H, Lennertz R, Sanders RD. Association between plasma tau and postoperative delirium incidence and severity: a prospective observational study. Br J Anaesth. 2021 Feb;126(2):458-466. doi: 10.1016/j.bja.2020.08.061. Epub 2020 Nov 20.'}, {'pmid': '35794069', 'type': 'BACKGROUND', 'citation': 'Liang F, Baldyga K, Quan Q, Khatri A, Choi S, Wiener-Kronish J, Akeju O, Westover MB, Cody K, Shen Y, Marcantonio ER, Xie Z. Preoperative Plasma Tau-PT217 and Tau-PT181 Are Associated With Postoperative Delirium. Ann Surg. 2023 Jun 1;277(6):e1232-e1238. doi: 10.1097/SLA.0000000000005487. Epub 2022 Jul 6.'}, {'pmid': '35864562', 'type': 'BACKGROUND', 'citation': 'Wang W, Ma Y, Liu Y, Wang P, Liu Y. Effects of Dexmedetomidine Anesthesia on Early Postoperative Cognitive Dysfunction in Elderly Patients. ACS Chem Neurosci. 2022 Aug 3;13(15):2309-2314. doi: 10.1021/acschemneuro.2c00173. Epub 2022 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia.', 'detailedDescription': 'to assess the effect of dexmedetomidine on serum Tau-217 protein through measuring serum Tau-217 protein preoperative and postoperative period and comparing the 2 measurements , assessing the cognitive dysfunction in the elderly patients and comparing the correlation between the cognitive dysfunction with serum tau-217 level also assessing the neuroprotective effect of dexmedetomidine on postoperative cognitive dysfunction and its relation with serum Tau-217 level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged \\> 65 years old, both genders, Basal Metabolic Index range 18.5 to less than 35 American Society of Anesthesiologists I - III with Glasgow Coma Scale 14-15 undergoing major surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Patients will be excluded if they refused the enrollment in our study, Glasgow Coma Scale\\<14 or if there is severe cardiac, liver or renal disease, patients have Alzehimer's Disease or any of the psychotic diseases, poorly educated patients and if there is any sensitivity to given drugs"}, 'identificationModule': {'nctId': 'NCT06366412', 'briefTitle': 'Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein.', 'organization': {'class': 'OTHER', 'fullName': 'Minia University Hospital'}, 'officialTitle': 'Effect of Dexmedetomidine on Serum Tau-217 Protein as a Biomarker for Post-operative Cognitive Dysfunction in Elderly Patients.', 'orgStudyIdInfo': {'id': 'serum Tau-217 in elderly'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': 'Will receive induction of general anesthesia by loading dose of dexmedetomidine (Precedex) 0.6 μg/kg over 10 minutes in a 20 ml micropump, fentanyl in a dose of 1 μg /kg, propofol 1-1.5 mg/kg, and endotracheal intubation will be facilitated by 0.5mg/kg of atracurium and maintenance of anesthesia will be achieved by dexmedetomidine in a dose of 0.3 μg/kg/hr on 50 ml micropump and isoflurane (1-2%) in oxygen-air mixture.', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Will receive induction of general anesthesia by infusion of normal saline 20 ml micropump over 10 min, fentanyl in a dose of 1 μg/kg, propofol 1-1.5 mg/kg and endotracheal intubation will be facilitated by 0.5mg/kg of atracurium and maintenance of anesthesia will be achieved by isoflurane (1-2%) in oxygen-air mixture and infusion of 50 ml/hr micropump of normal saline.', 'interventionNames': ['Other: normal saline']}], 'interventions': [{'name': 'Dexmedetomidine Hydrochloride', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'dexmedetomidine effect in preventing postoperative cognitive dysfunction on elderly patients undergoing major surgery guided with serum Tau-217 protein.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'normal saline', 'type': 'OTHER', 'description': 'normal saline will be administrated in placebo group', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Arwa essam Essam, assistant lecturer', 'role': 'CONTACT', 'email': 'arwty26@gmail.com', 'phone': '+201017565658'}], 'facility': 'Arwa Essam', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Arwa Essam Anwar, Assistant Lecturer', 'role': 'CONTACT', 'email': 'arwty26@gmail.com', 'phone': '+201017565658'}, {'name': 'Amr Nady Abd Elrazik, Assistant Lecturer', 'role': 'CONTACT', 'phone': '+201023451177'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Arwa Essam', 'investigatorAffiliation': 'Minia University Hospital'}}}}