Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 7:21 PM
Study NCT ID:
NCT05664295
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orexin-A Levels in Insomnia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orexin-A Levels', 'timeFrame': 'at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation', 'description': 'plasma OXA levels anesthesia induction and after anesthesia in insomnia patients'}, {'measure': 'Orexin-A Levels', 'timeFrame': 'at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation', 'description': 'plasma OXA levels anesthesia induction and after anesthesia in control group'}], 'secondaryOutcomes': [{'measure': 'recovery time from general anesthesia', 'timeFrame': 'time of eyes opening and time of extubation', 'description': 'The relationship between plasma OXA levels and recovery times from anesthesia in insomnia patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '30862990', 'type': 'BACKGROUND', 'citation': 'Bollu PC, Kaur H. Sleep Medicine: Insomnia and Sleep. Mo Med. 2019 Jan-Feb;116(1):68-75.'}, {'pmid': '17243641', 'type': 'BACKGROUND', 'citation': 'Hirota K. [Orexinergic neurons and noradrenergic awakening system in general anesthesia]. Masui. 2007 Jan;56(1):9-18. Japanese.'}, {'pmid': '27687412', 'type': 'BACKGROUND', 'citation': 'Erden V, Abitagaoglu S, Guler C, Dogan Z, Kirgezen S, Abut Y. Insomnia may increase anesthetic requirement. J Clin Anesth. 2016 Nov;34:367-72. doi: 10.1016/j.jclinane.2016.05.020. Epub 2016 Jun 4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the emergence of anesthesia. In the literature, investigators could not attain any studies about the arousal of insomnia patients from anesthesia. In this study, the effect of this peptide on the emergence process from anesthesia was investigated by comparing plasma OXA levels before and after anesthesia in insomnia patients.', 'detailedDescription': 'ASA (American Society of Anesthesiologists) I-II patients aged 18-65 years who underwent elective laparoscopic cholecystectomy were included in the study. Patients were evaluated with the Jenkins Sleep Disorders scale and Epworth Sleepiness scale during preoperative examination and were divided into insomnia and control groups. Blood samples were obtained for OXA and glucose levels at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation. The times from stopping anesthesia to eyes opening and extubation and end-tidal sevoflurane concentrations at these time points were recorded.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients undergo elective laparoscopic cholecystectomy under general anesthesia', 'genderDescription': 'male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male patients undergo elective laparoscopic cholecystectomy under general anesthesia\n* Between 18-65 age\n* ASA I-II\n\nExclusion Criteria:\n\n* ASA≥III\n* Patients with obstructive sleep apnea syndrome\n* Bleeding over 500 ml\n* Allergic to anesthetic agents\n* Patients with a BMI \\> 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT05664295', 'briefTitle': 'Orexin-A Levels in Insomnia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Comparison of Plasma Orexin-A Levels and Awakening Time From Anesthesia in Patients With and Without Insomnia Who Had Laparoscopic Cholecystectomy Under General Anesthesia', 'orgStudyIdInfo': {'id': '14/III'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'insomnia patients', 'description': 'Jenkins Sleep Disorders scale skor \\>1 and Epworth Sleepiness scale skor \\>9', 'interventionNames': ['Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale']}, {'label': 'noninsomniacs', 'description': 'Jenkins Sleep Disorders scale skor \\<2 and Epworth Sleepiness scale skor \\<10', 'interventionNames': ['Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale']}], 'interventions': [{'name': 'Jenkins Sleep Disorders scale and Epworth Sleepiness scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Jenkins Sleep Disorders scale and Epworth Sleepiness scale', 'armGroupLabels': ['insomnia patients', 'noninsomniacs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sitki Kocman University', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'melike Korkmaz Toker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology and Reanimation', 'investigatorFullName': 'Melike Korkmaz Toker', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}