Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-07 @ 6:20 AM
Study NCT ID:
NCT02549768
Status:
UNKNOWN
Last Update Posted:
2016-10-12
First Post:
2015-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2015-09-06', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol plasmatic levels', 'timeFrame': '24 hours after surgery', 'description': 'Venous blood sample'}], 'secondaryOutcomes': [{'measure': 'Adrenocorticotropin hormone', 'timeFrame': 'One hour after surgery, 24 hours after surgery, 48 hours after surgery', 'description': 'Venous blood sample'}, {'measure': 'Hemodynamics', 'timeFrame': 'From start of anesthesia to end of anesthesia', 'description': 'Heart rate and arterial pressure'}, {'measure': 'Nausea and vomiting', 'timeFrame': '24 hours after surgery', 'description': 'Semiquantitative measure'}, {'measure': 'Pain', 'timeFrame': '24 hours after surgery', 'description': 'By visual analogue scale'}, {'measure': 'Patient comfort', 'timeFrame': '24 hours after discharge from hospital', 'description': 'Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)'}, {'measure': 'Diabetes insipidus incidence', 'timeFrame': '24 hours after surgery and 3 months after surgery', 'description': 'Clinical diagnosis by urine output (polyuria over 3 liters or urine per day) and/or hypernatremia (plasmatic sodium over 145 meq/L)'}, {'measure': 'Cerebrospinal fluid fistula', 'timeFrame': '3 months after surgery', 'description': 'Clinical diagnosis made by neurosurgeon'}, {'measure': 'Cortisol plasmatic levels', 'timeFrame': '1 hour after surgery, 48 hours after surgery, 3 months after surgery', 'description': 'Venous blood sample'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Pituitary', 'Transsphenoidal', 'Cortisol'], 'conditions': ['Pituitary Neoplasms']}, 'referencesModule': {'references': [{'pmid': '25517050', 'type': 'BACKGROUND', 'citation': 'Carrasco CA, Villanueva G P. [Selective use of glucocorticoids during the perioperative period of transsphenoidal surgery for pituitary tumors]. Rev Med Chil. 2014 Sep;142(9):1113-9. doi: 10.4067/S0034-98872014000900004. Spanish.'}, {'pmid': '3372683', 'type': 'BACKGROUND', 'citation': 'Hout WM, Arafah BM, Salazar R, Selman W. Evaluation of the hypothalamic-pituitary-adrenal axis immediately after pituitary adenomectomy: is perioperative steroid therapy necessary? J Clin Endocrinol Metab. 1988 Jun;66(6):1208-12. doi: 10.1210/jcem-66-6-1208.'}, {'pmid': '19098618', 'type': 'BACKGROUND', 'citation': 'Ali Z, Prabhakar H, Bithal PK, Dash HH. Bispectral index-guided administration of anesthesia for transsphenoidal resection of pituitary tumors: a comparison of 3 anesthetic techniques. J Neurosurg Anesthesiol. 2009 Jan;21(1):10-5. doi: 10.1097/ANA.0b013e3181855732.'}, {'pmid': '10730549', 'type': 'BACKGROUND', 'citation': 'Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.'}, {'pmid': '25493927', 'type': 'BACKGROUND', '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': '15757125', 'type': 'BACKGROUND', 'citation': 'Raekallio MR, Kuusela EK, Lehtinen ME, Tykkylainen MK, Huttunen P, Westerholm FC. Effects of exercise-induced stress and dexamethasone on plasma hormone and glucose concentrations and sedation in dogs treated with dexmedetomidine. Am J Vet Res. 2005 Feb;66(2):260-5. doi: 10.2460/ajvr.2005.66.260.'}, {'pmid': '16790625', 'type': 'BACKGROUND', 'citation': 'Mukhtar AM, Obayah EM, Hassona AM. The use of dexmedetomidine in pediatric cardiac surgery. Anesth Analg. 2006 Jul;103(1):52-6, table of contents. doi: 10.1213/01.ane.0000217204.92904.76.'}, {'pmid': '14740262', 'type': 'BACKGROUND', 'citation': 'Nomikos P, Ladar C, Fahlbusch R, Buchfelder M. Impact of primary surgery on pituitary function in patients with non-functioning pituitary adenomas -- a study on 721 patients. Acta Neurochir (Wien). 2004 Jan;146(1):27-35. doi: 10.1007/s00701-003-0174-3. Epub 2004 Jan 7.'}, {'pmid': '22824921', 'type': 'BACKGROUND', 'citation': 'Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.'}]}, 'descriptionModule': {'briefSummary': 'Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation to cortisol levels during postoperative period.', 'detailedDescription': 'Transsphenoidal resection of pituitary tumors is the neurosurgical procedure of choice to remove most of the tumors of the sellar region. Sometimes the intervention produces dysfunction of the hypothalamic-pituitary axis, and although most are transient, the risk associated with post-operative hypocortisolism determines its evaluation early in the postoperative period and the possibility of steroidal supplementation posteriorly. It is described that dexmedetomidine can be used as an adjuvant drug in this type of surgery being useful in reduction of total consumption of opioids and anesthetic gases, maintain hemodynamic stability and less time to recovery from anesthesia. Due to its sympatholytic effect, dexmedetomidine has been found to alter the intraoperative common neuroendocrine response generating lower levels of cortisol in the postoperative period than patients in which is not used.\n\nThe main objective of this study is to evaluate corticosteroid axis response (cortisol and adrenocorticotropic hormone) in patients undergoing transsphenoidal surgery under anesthesia with dexmedetomidine. A single-center randomized double-blind clinical trial will be conducted that will compare two groups of patients, one of which will be given dexmedetomidine (Dex group) and another group who will receive a placebo (control group). In addition the incidence of perioperative complications (nausea, vomiting, diabetes insipidus), intraoperative hemodynamics and patient comfort. The investigators expect that the normal stress response to surgery measured by cortisol and adrenocorticotropic hormone in the postoperative period will be reduced in the dexmedetomidine arm. This effect should be transient and attributed to use of dexmedetomidine and not to surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I or II.\n* Pituitary tumour: non-functional macroadenoma, Rathke's cleft cyst, acromegaly.\n* Normal hypothalamic-pituitary-adrenal axis by hormone levels measurement previous to surgery.\n\nExclusion Criteria:\n\n* Cushing disease.\n* Pituitary apoplexy.\n* Craniopharyngioma.\n* Chronic corticosteroid use.\n* Hemodynamic instability.\n* Altered consciousness (Glasgow Coma Scale score less than 15).\n* Atrioventricular block in any degree.\n* Preoperative bradycardia.\n* Alpha 2 agonist use (clonidine, alpha-methyldopa)\n* Pregnancy or breast feeding.\n* Known allergy to any of the study drugs."}, 'identificationModule': {'nctId': 'NCT02549768', 'briefTitle': 'Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Effect of Dexmedetomidine as Anesthetic Coadjuvant on Plasmatic Cortisol Response in Transsphenoidal Surgery for Pituitary Tumors', 'orgStudyIdInfo': {'id': '15-095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Use of crystalloid solution (sodium chloride 0.9%), injection pump programmed with drug "Dexmedetomidine" with 1 mcg/kg in 10 minutes, infusion 0.7 mcg/kg/h.', 'interventionNames': ['Drug: Sodium Chloride 0.9%']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'At start of anesthesia, bolus of 1 mcg/kg of dexmedetomidine over 10 minutes and then infusion of 0.7 mcg/kg/h during surgery will be administered.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Sodium Chloride 0.9%', 'type': 'DRUG', 'otherNames': ['Saline solution'], 'description': 'Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8330024', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Fernando R Altermatt, MSc', 'role': 'CONTACT', 'email': 'fernando.altermatt@gmail.com', 'phone': '56-2-23543270'}, {'name': 'Hernan E Auad, MD', 'role': 'CONTACT', 'email': 'hernan_auad@hotmail.com', 'phone': '56-2-23543270'}], 'facility': 'Division de Anestesia - Pontificia Universidad Catolica de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Juan C Pedemonte, MD', 'role': 'CONTACT', 'email': 'jcpedemo@gmail.com', 'phone': '56-2-23543270'}, {'name': 'Pablo Villanueva, MD', 'role': 'CONTACT', 'email': 'pablovillanueva@neurocirugiauc.cl', 'phone': '56-2-23543465'}], 'overallOfficials': [{'name': 'Juan C Pedemonte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physician'}, {'name': 'Pablo Villanueva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisstant adjunct professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}