Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT03499132
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2018-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Different Anesthetic Procedures on Sleep Disorder Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2018-04-08', 'studyFirstSubmitQcDate': '2018-04-08', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea index change', 'timeFrame': '4 nights after surgery', 'description': 'Changes (post-pre) in apnea-hypopnea index 4 nights post surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia, obstructive sleep apnea'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '24158050', 'type': 'BACKGROUND', 'citation': 'Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041.'}, {'pmid': '3354874', 'type': 'BACKGROUND', 'citation': 'Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.'}, {'pmid': '1128555', 'type': 'BACKGROUND', 'citation': 'Weil JV, McCullough RE, Kline JS, Sodal IE. Diminished ventilatory response to hypoxia and hypercapnia after morphine in normal man. N Engl J Med. 1975 May 22;292(21):1103-6. doi: 10.1056/NEJM197505222922106.'}, {'pmid': '8024126', 'type': 'BACKGROUND', 'citation': 'Dahan A, van den Elsen MJ, Berkenbosch A, DeGoede J, Olievier IC, van Kleef JW, Bovill JG. Effects of subanesthetic halothane on the ventilatory responses to hypercapnia and acute hypoxia in healthy volunteers. Anesthesiology. 1994 Apr;80(4):727-38. doi: 10.1097/00000542-199404000-00004.'}, {'pmid': '7661348', 'type': 'BACKGROUND', 'citation': 'van den Elsen M, Dahan A, DeGoede J, Berkenbosch A, van Kleef J. Influences of subanesthetic isoflurane on ventilatory control in humans. Anesthesiology. 1995 Sep;83(3):478-90. doi: 10.1097/00000542-199509000-00006.'}, {'pmid': '24346178', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.'}, {'pmid': '29300271', 'type': 'BACKGROUND', 'citation': 'Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by partial or complete upper airway obstructions during sleep. OSA is associated with major comorbidities and perioperative complications. These complications are caused not only by the OSA itself, but also by exacerbations of this syndrome during the perioperative period (1). Benzodiazepines, volatile anesthetics and opioids may lead to lower hypoxia and hypercapnia sensitivity and may cause respiratory depression (2-5). Therefore, preference of neuraxial blockades and avoidance of opioids has been suggested for patients with OSA (6). However, there is still lack of evidence to evaluate the effects of various anesthesia procedures on OSA (6,7). We hypothesize different anesthetic procedures will have different effect on OSA exacerbations in the postoperative period. Accordingly, the aim of this study is to compare the number of sleep disordered breathing episodes in the postoperative period in patients with different anesthetic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients undergoing elective orthopedic surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective orthopedic surgery\n\nExclusion Criteria:\n\n* already diagnosed sleep disorder breathing\n* continuous positive airway pressure therapy\n* tracheostomy\n* American Society of Anesthesiologists class IV-V'}, 'identificationModule': {'nctId': 'NCT03499132', 'briefTitle': 'Influence of Different Anesthetic Procedures on Sleep Disorder Breathing', 'organization': {'class': 'OTHER', 'fullName': "St. Anne's University Hospital Brno, Czech Republic"}, 'officialTitle': 'Influence of Different Anesthetic Procedures on Sleep Disorder Breathing in Adult Patients Undergoing Elective Surgery', 'orgStudyIdInfo': {'id': 'IIT/2017/30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anesthesia (with opioids)', 'description': 'orthopedic surgery plus general anesthesia', 'interventionNames': ['Procedure: anesthesia']}, {'label': 'Epidural anesthesia (without opioids)', 'description': 'orthopedic surgery plus epidural anesthesia (without opioids use)', 'interventionNames': ['Procedure: anesthesia']}, {'label': 'Subarachnoid anesthesia (with opioids)', 'description': 'orthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid)', 'interventionNames': ['Procedure: anesthesia']}, {'label': 'Regional anesthesia (without opioids)', 'description': 'orthopedic surgery plus regional anesthesia (peripheral nerve block, continous or single shot, without opioid use)', 'interventionNames': ['Procedure: anesthesia']}], 'interventions': [{'name': 'anesthesia', 'type': 'PROCEDURE', 'description': 'Different anesthetic procedures', 'armGroupLabels': ['Epidural anesthesia (without opioids)', 'General anesthesia (with opioids)', 'Regional anesthesia (without opioids)', 'Subarachnoid anesthesia (with opioids)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65691', 'city': 'Brno', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': "St. Anne's University Hospital Brno", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Ivan Cundrle, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Anne's University Hospital Brno"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Ivan Cundrle', 'investigatorAffiliation': "St. Anne's University Hospital Brno, Czech Republic"}}}}