Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-26 @ 9:09 PM
Study NCT ID:
NCT03132259
Status:
UNKNOWN
Last Update Posted:
2017-05-30
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach', 'timeFrame': '24 hours', 'description': 'Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr what is the dose proper and hemodynamic changes. Hemodynamic change means BP is lower than 20% of baseline more than 10minute'}], 'secondaryOutcomes': [{'measure': 'Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor', 'timeFrame': '24 hours', 'description': 'Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexmedethomidine'], 'conditions': ['Pituitary Tumor']}, 'referencesModule': {'references': [{'pmid': '25493927', 'type': 'RESULT', 'citation': 'Gopalakrishna KN, Dash PK, Chatterjee N, Easwer HV, Ganesamoorthi A. Dexmedetomidine as an Anesthetic Adjuvant in Patients Undergoing Transsphenoidal Resection of Pituitary Tumor. J Neurosurg Anesthesiol. 2015 Jul;27(3):209-15. doi: 10.1097/ANA.0000000000000144.'}, {'pmid': '26229757', 'type': 'RESULT', 'citation': 'Anjum N, Tabish H, Debdas S, Bani HP, Rajat C, Anjana Basu GD. Effects of dexmedetomidine and clonidine as propofol adjuvants on intra-operative hemodynamics and recovery profiles in patients undergoing laparoscopic cholecystectomy: A prospective randomized comparative study. Avicenna J Med. 2015 Jul-Sep;5(3):67-73. doi: 10.4103/2231-0770.160231.'}, {'pmid': '26329913', 'type': 'RESULT', 'citation': 'Polat R, Peker K, Baran I, Bumin Aydin G, Topcu Guloksuz C, Donmez A. Comparison between dexmedetomidine and remifentanil infusion in emergence agitation during recovery after nasal surgery: A randomized double-blind trial. Anaesthesist. 2015 Oct;64(10):740-6. doi: 10.1007/s00101-015-0077-8. Epub 2015 Sep 2.'}, {'pmid': '25293480', 'type': 'RESULT', 'citation': 'Karwacki Z, Niewiadomski S, Rzaska M, Witkowska M. The effect of bispectral index monitoring on anaesthetic requirements in target-controlled infusion for lumbar microdiscectomy. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):284-8. doi: 10.5603/AIT.2014.0046.'}]}, 'descriptionModule': {'briefSummary': 'Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli during various stages of surgery. None of routinely used anesthetic agents effectively blunts the undesirable hemodynamic responses, and therefore usually there is a need to use increased doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because its sympatholytic and antinociceptive properties may ensure optimal intraoperative hemodynamic stability during critical moments of surgical manipulation. In addition, DEX reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic requirements', 'detailedDescription': 'DEX as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing TNTS resection of pituitary tumor. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age18-65\n2. ASA 1-2\n3. Elective TNTS resection of Pituitary Tumor\n4. No narcotic before surgery as premedication\n5. Able to Extubate\n\nExclusion Criteria:\n\n1. GCS less than 15\n2. Preoperative Heart Rate less than 50 beat/min\n3. No Beta-Blockers\n4. Pregnant patients\n5. Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist\n6. Hemodynamic unstable\n7. Systolic BP more than 160mmHg\n8. CAD\n9. Renal insuffuciency\n10. Allergy in dexmedethomidine and opioid\n11. BMI more than 30\n12. Denied consent'}, 'identificationModule': {'nctId': 'NCT03132259', 'briefTitle': 'Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach', 'orgStudyIdInfo': {'id': '116/2559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose dexmedethomidine', 'description': 'High dose is 0.5 microgram/kg/hr', 'interventionNames': ['Drug: high dose dexmedethomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose dexmedethomidine', 'description': 'Low dose is 0.2 microgram/kg/hr', 'interventionNames': ['Drug: low dose dexmedethomidine']}], 'interventions': [{'name': 'high dose dexmedethomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Dexmedethomidine continuous drip 0.5 mcg/kg/hr a', 'armGroupLabels': ['High dose dexmedethomidine']}, {'name': 'low dose dexmedethomidine', 'type': 'DRUG', 'description': 'Dexmedethomidine continuous drip 0.2 mcg/kg/hr', 'armGroupLabels': ['Low dose dexmedethomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Saipin Muangman, physician', 'role': 'CONTACT'}], 'facility': 'Faculy of Medicine Siriraj hospital Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Saipin Muangman, physician', 'role': 'CONTACT', 'email': 'saipinnoolek@gmail.com', 'phone': '6681 3747786'}, {'name': 'Sirinuttakul Akkaworakit, physician', 'role': 'CONTACT', 'email': 'gnig.ging@gmail.com', 'phone': '087- 675-8434'}], 'overallOfficials': [{'name': 'Saipin Muangman, physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisted Professor', 'investigatorFullName': 'SMuangman', 'investigatorAffiliation': 'Mahidol University'}}}}