Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-01-18 @ 12:32 AM
Study NCT ID:
NCT02510612
Status:
UNKNOWN
Last Update Posted:
2015-07-29
First Post:
2015-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sedation level', 'timeFrame': 'from 5 minutes before medication to 10 minutes after Dexmedetomidine discontinuance，length of time frame is about 2 hours', 'description': 'Ramsay score and BIS will be recorded before medication,5 min after medication, medication ending, 5 and 10 min after medication'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': 'recorded at before medication,5 min after medication, medication ending, 5 and 10 min after medication, before intubation, after intubation, after skin incision,60 minutes after skin incision, after extubation,first day after operation'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': '10 min after medication, before intubation, after intubation, after skin incision,60 minutes after skin incision, after extubation,first day after operation'}, {'measure': 'blood glucose measured by Biochemical test', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': 'it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation'}, {'measure': 'cortisol measured by Biochemical test', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': 'it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation'}, {'measure': 'insulin measured by Biochemical test', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': 'it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation'}, {'measure': 'adrenaline measured by Biochemical test', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': 'it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation'}, {'measure': 'noradrenaline measured by Biochemical test', 'timeFrame': 'participants will be followed from operation day to first postoperative day，an expected average of 2 days', 'description': 'it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Diabetic', 'glycometabolism', 'sedation'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': "Dexmedetomidine's Sedative Effect on Diabetic Patient", 'detailedDescription': 'Dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. The pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. This study is to evaluate whether the use of dexmedetomidine is helpful to Diabetic Patient through its antisympathetic effect'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 60\n* Selective epigastrium surgery\n* In\n\nExclusion Criteria:\n\n* American Society of Anesthesiology (ASA) Physical Status\\>3\n* Duration of operation \\>3 hours\n* Hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency'}, 'identificationModule': {'nctId': 'NCT02510612', 'acronym': 'dadpgm', 'briefTitle': "Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism", 'organization': {'class': 'OTHER', 'fullName': "Shaanxi Provincial People's Hospital"}, 'officialTitle': "Perioperative Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism", 'orgStudyIdInfo': {'id': '20150618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'Patients in group D will be given dexmedetomidine during anesthesia induction and maintenance phase respectively.In induction phase infuse 1μg/Kg of dexmedetomidine in 10 minutes， the speed in maintenance phase is 0.4μg/Kg.h', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Patients in group P will be given normal saline during anesthesia induction and maintenance phase', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Yi Si'], 'description': 'During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Dexmedetomidine(D) group, patient will be given dexmedetomidine 1μg/Kg for 10 minutes In anesthesia maintenance, D group will be given dexmedetomidine 0.4μg/Kg.h until 40 minutes before the end of surgery', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Placebo(P) group, patient will be given placebo for 10 minutes In anesthesia maintenance, D group will be given placebo until 40 minutes before the end of surgery', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yulong Song', 'role': 'CONTACT', 'phone': '86-13519185656'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shaanxi Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthetist', 'investigatorFullName': 'Song yulong', 'investigatorAffiliation': "Shaanxi Provincial People's Hospital"}}}}