Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 7:00 AM
Study NCT ID:
NCT06037135
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2023-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Infusion During Laparoscopic Adrenalectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010673', 'term': 'Pheochromocytoma'}], 'ancestors': [{'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))', 'timeFrame': 'during operation'}, {'measure': 'Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)', 'timeFrame': 'during operation'}, {'measure': 'Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)', 'timeFrame': 'during operation'}, {'measure': 'Intraoperative hemodynamic stability (maximum HR during surgery)', 'timeFrame': 'during operation'}, {'measure': 'Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)', 'timeFrame': 'during operation'}, {'measure': 'Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)', 'timeFrame': 'during operation'}], 'secondaryOutcomes': [{'measure': 'levels of catecholamines', 'timeFrame': 'immediately after anesthesia induction', 'description': 'the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points'}, {'measure': 'levels of catecholamines', 'timeFrame': 'immediately after removal of the pheochromocytoma', 'description': 'the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points'}, {'measure': 'levels of catecholamines', 'timeFrame': 'immediately after the completion of surgery', 'description': 'the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pheochromocytoma']}, 'descriptionModule': {'briefSummary': 'The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ages of 20 and 70\n2. American Society of Anesthesiologists(ASA) physical status classification I to III,\n3. planned laparoscopic adrenalectomy for pheochromocytoma.\n\nExclusion Criteria:\n\n1. emergency operation,\n2. re-operation,\n3. combined surgery with other departments,\n4. body mass index (BMI) \\>32 kg/m2,\n5. history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,\n6. uncontrolled hypertension (diastolic blood pressure \\>110mmHg)\n7. bradycardia (heart rate \\< 40 beats per minute),\n8. history of heart failure, hepatic and/or renal failure,\n9. history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),\n10. history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT06037135', 'briefTitle': 'Dexmedetomidine Infusion During Laparoscopic Adrenalectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study', 'orgStudyIdInfo': {'id': '4-2012-0577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine group', 'description': 'In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.', 'interventionNames': ['Drug: dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.', 'interventionNames': ['Drug: 0.9% normal saline']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'description': 'In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.', 'armGroupLabels': ['dexmedetomidine group']}, {'name': '0.9% normal saline', 'type': 'DRUG', 'description': 'In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Jun Oh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}