Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT03109418
Status:
TERMINATED
Last Update Posted:
2019-12-19
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adamsturdivant@uabmc.edu', 'phone': '205-934-4042', 'title': 'Adam Sturdivant', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'OSA patients will receive standard inhaled anesthesia with normal saline infusion\n\nControl: OSA patients receiving standard inhaled anesthesia combined with normal saline', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine Group', 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.\n\nKetamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'OSA patients will receive standard inhaled anesthesia with normal saline infusion\n\nControl: OSA patients receiving standard inhaled anesthesia combined with normal saline'}, {'id': 'OG001', 'title': 'Ketamine Group', 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.\n\nKetamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight'}], 'timeFrame': 'up to 24 hours postoperatively', 'description': 'Visual Analog Scale pain rating', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated. Data was not collected.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'OSA patients will receive standard inhaled anesthesia with normal saline infusion\n\nControl: OSA patients receiving standard inhaled anesthesia combined with normal saline'}, {'id': 'OG001', 'title': 'Ketamine Group', 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.\n\nKetamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight'}], 'timeFrame': 'At 24 hrs post-op', 'description': 'Patients will rate their quality of anesthesia services', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were not analyzed due to study being terminated. Data was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'OSA patients will receive standard inhaled anesthesia with normal saline infusion\n\nControl: OSA patients receiving standard inhaled anesthesia combined with normal saline'}, {'id': 'FG001', 'title': 'Ketamine Group', 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.\n\nKetamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Three participants were excluded prior to randomization due to the following reasons:\n\n1. The patient was experiencing on-going neurological issues and was therefore removed from the study prior to randomization.\n2. The patient missed his/her own surgery date.\n3. The patient ended up having outpatient surgery, and was therefore excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'OSA patients will receive standard inhaled anesthesia with normal saline infusion\n\nControl: OSA patients receiving standard inhaled anesthesia combined with normal saline'}, {'id': 'BG001', 'title': 'Ketamine Group', 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.\n\nKetamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Males', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-07-19', 'size': 13692877, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-01T11:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Recruitment challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2017-04-06', 'resultsFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-18', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': 'up to 24 hours postoperatively', 'description': 'Visual Analog Scale pain rating'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction Score', 'timeFrame': 'At 24 hrs post-op', 'description': 'Patients will rate their quality of anesthesia services'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine', 'Postoperative morbidity'], 'conditions': ['Sleep Apnea', 'Obstructive Sleep Apnea', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.', 'detailedDescription': 'Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 19-100\n* scheduled to undergo general ENT or Orthopedic Surgery\n* diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).\n\nExclusion Criteria:\n\n* positive pregnancy test\n* ASA \\> III\n* history of alcohol or narcotic abuse in last 90 days\n* significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)\n* significant psychiatric or neurologic disease\n* history of significant hepatic or renal disease (baseline creatinine\\>1.5)\n* history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP\n* increased IOP\n* severe arrhythmias\n* history of delirium\n* history of hallucinations\n* history of psychosis\n* history of uncontrolled seizures\n* potential risk for malignant hyperthermia (family history)\n* history of difficult intubation that would preclude standard induction of anesthesia\n* prisoners\n* persons who are mentally impaired\n* non-English speakers'}, 'identificationModule': {'nctId': 'NCT03109418', 'briefTitle': 'Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study', 'orgStudyIdInfo': {'id': 'F160224001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'OSA patients will receive standard inhaled anesthesia with normal saline infusion', 'interventionNames': ['Procedure: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine Group', 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight', 'armGroupLabels': ['Ketamine Group']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'OSA patients receiving standard inhaled anesthesia combined with normal saline', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Department of Anesthesiology and Perioperative Medicine', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Peter A Nagi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Peter A. Nagi', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}