Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT06793150
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2024-07-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries
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': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'group d maintaiance with dexmedetomidine group r maintainence with remifentanile'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'group d maintaiance with dexmedetomidine group r maintainence with remifentanile'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-18', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2025-01-18', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive dysfunction', 'timeFrame': 'preoperative, postoperative 24th hour and 3rd week', 'description': 'Our primary objective is comparing postoperative cognitive dysfunction using the Mini-Mental State Examination after anesthesia 24 hours and 3 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'comparing anesthesia and opioid free anesthesia', 'timeFrame': 'preoperative, postoperative 24th hour and 3rd week', 'description': 'Our secondary objective is to compare the times of eye opening and extubation after opioid free anesthesia and anesthesia with opioid.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Dysfunction', 'Opioid Free Anesthesia']}, 'referencesModule': {'references': [{'pmid': '31765741', 'type': 'BACKGROUND', 'citation': 'Lin X, Chen Y, Zhang P, Chen G, Zhou Y, Yu X. The potential mechanism of postoperative cognitive dysfunction in older people. Exp Gerontol. 2020 Feb;130:110791. doi: 10.1016/j.exger.2019.110791. Epub 2019 Nov 23.'}, {'pmid': '30519008', 'type': 'BACKGROUND', 'citation': 'Kotekar N, Shenkar A, Nagaraj R. Postoperative cognitive dysfunction - current preventive strategies. Clin Interv Aging. 2018 Nov 8;13:2267-2273. doi: 10.2147/CIA.S133896. eCollection 2018.'}, {'pmid': '32530891', 'type': 'BACKGROUND', 'citation': 'Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the patients undergoing pituitary surgery in our clinic have examined in two groups. In the first group, anesthesia maintenance was provided with remifentanil and propofol infusion. In the second group, anesthesia maintenance was provided with dexmedetomidine and propofol infusion. Demographic data, vital signs during the operation, wake-up time, extubation time, and drug consumption amounts were recorded. The mini-mental test was applied preoperatively, 24 hours postoperatively, and 3 weeks postoperatively to examine whether there is a difference in cognitive dysfunction between the two groups.', 'detailedDescription': 'Postoperative cognitive dysfunction refers to disorders affecting orientation, attention, perception, consciousness, and judgment that develop after surgery. It is a common postoperative complication and a serious threat to the quality of life, particularly for elderly patients. Strategies to prevent surgery and anesthesia-induced cognitive dysfunction are being investigated, considering the choice and depth of anesthesia, perioperative anesthetic and other drugs, and surgical strategy.\n\nOpioid-free anesthesia involves the administration of intraoperative anesthesia without the use of intraoperative opioids. Currently available non-opioid drugs include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) (ketorolac, ibuprofen, celecoxib), alpha-2 agonists (dexmedetomidine, clonidine, tizanidine), and N-methyl-D-aspartate (NMDA) receptor antagonists (ketamine). Dexmedetomidine (DEX) is an alpha-2 adrenoceptor agonist with a selectivity ratio of 1600:1 (α2:α1). It promotes sedation by acting on the α2 receptors of the locus coeruleus and produces analgesia by reducing the release of substance P in the spinal cord dorsal horn.\n\nThe goals of opioid use during anesthesia are to reduce the need for hypnotic agents and provide effective analgesia. However, the potential side effects of opioids can be described as having a threefold negative impact, ranging from sudden adverse reactions in the patient to the long-term sequelae of chronic effects.\n\nIn this study, the patients undergoing pituitary surgery in our clinic have examined in two groups. In the first group, anesthesia maintenance was provided with remifentanil and propofol infusion. In the second group, anesthesia maintenance was provided with dexmedetomidine and propofol infusion. Demographic data, vital signs during the operation, wake-up time, extubation time, and drug consumption amounts were recorded. The mini-mental test was applied preoperatively, 24 hours postoperatively, and 3 weeks postoperatively to examine whether there is a difference in cognitive dysfunction between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing transsphenoidal pituitary elective surgery\n* Patients classified as ASA (American Society of Anesthesiologists) physical status classification I-III\n* Patients aged between 18 and 65 years\n\nExclusion Criteria:\n\n* Patients scheduled for emergency surgery\n* Patients classified as ASA (American Society of Anesthesiologists) physical status classification IV-V\n* Patients with psychiatric disorders\n* Patients with a history of stroke, dementia, electrolyte disturbances, or serious liver and/or kidney disease\n* Patients with a history of substance abuse"'}, 'identificationModule': {'nctId': 'NCT06793150', 'briefTitle': 'Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Comparison of the Effects of Opioid-Based Anesthesia Versus Opioid-Free Anesthesia on Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries', 'orgStudyIdInfo': {'id': 'AIBU-AR-GÇÖ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group d', 'description': 'group d anesthesia maintaiance with dexmedetomidine', 'interventionNames': ['Drug: dexmedetomidin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group r', 'description': 'group r anesthesia maintainence with remifentanile', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['ultiva'], 'description': 'A comparison will be made by maintaining one group with remifentanil and the other with dexmedetomidine.', 'armGroupLabels': ['group r']}, {'name': 'dexmedetomidin', 'type': 'DRUG', 'otherNames': ['sedadomid'], 'description': 'A comparison will be made by maintaining one group with remifentanil and the other with dexmedetomidine.', 'armGroupLabels': ['group d']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Gökçe Çile Özer', 'investigatorAffiliation': 'Kocaeli University'}}}}