[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644533":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":91,"collaborators":62,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":62,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":62,"enrollmentInfo":101,"targetDuration":62,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":70,"whyStopped":62,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Chicago","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG)","ACTIVE_COMPARATOR","Arm A (TIVA): Induction and maintenance intravenously (propofol, dexmedetomidine, fentanyl, hydromorphone); no volatile agents. Anesthetic depth titration based on clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring.",[13,14],"Combination Product: Total IntraVenous Anesthesia (TIVA)","Device: Electroencephalogram (EEG)",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm B - Spinal Block with Electroencephalogram (EEG)","Arm B (Spinal): Single-shot intrathecal mepivacaine-2%, 3.0 milliliters (mL) per institutional standard. Light propofol sedation is permitted at clinician discretion, titrated to comfort and clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring.",[19,14],"Combination Product: Spinal-Block",[21,31,41],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Total IntraVenous Anesthesia (TIVA)","Total IntraVenous Anesthesia - to achieve deep-sedation via chemical analgesic (propofol, dexmedetomidine, fentanyl, hydromorphone); continuous intravenous infusion.",[9],[27,28,29,30],"General Anesthesia","Systemic Anesthesia","TIVA","Deep Sedation",{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Spinal-Block","Spinal-block (mepivacaine 2%, 3.0 mL)\n\nClinician discretion to administer light-sedation with intravenously infused propofol during surgery.",[16],[36,37,38,39,40],"Regional Anesthesia","Nerve-Block","Field-Block","Local Anesthesia","Light Sedation",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DEVICE","Electroencephalogram (EEG)","Non-invasive continuous neurological (Neuro) monitoring device, e.g., Bi-spectral (BIS), recording electrical activity of the brain via adhesive scalp electrodes, which transmit neuro-activity during sedation.",[9,16],[47,48,49,50,51],"EEG","Bi-spectral Index monitor (BIS)","BIS","Brain Monitoring","Neurological (Neuro) Monitoring",[53],{"name":54,"affiliation":55,"role":56},"Zheng Xie, MD, PhD","University of Chicago, Department of Anesthesia and Critical Care","PRINCIPAL_INVESTIGATOR",[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Frank T Brown Jr, MA","CONTACT","773-834-5778",null,"ftbrownjr@uchicagomedicine.org",{"name":54,"role":60,"phone":65,"phoneExt":62,"email":66},"773-753-1880","JXie@bsd.uchicago.edu",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University of Chicago Medical Center","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-87.65005,41.85003,{"lat":80,"lon":79},[83,84,87,88],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},{"name":85,"role":60,"phone":86,"phoneExt":62,"email":66},"Zheng (Jimmy) Xie, MD, PhD","773-753-1880, pager: 1963",{"name":85,"role":56,"phone":62,"phoneExt":62,"email":62},{"name":89,"role":90,"phone":62,"phoneExt":62,"email":62},"Robert Fong, MD, PhD","SUB_INVESTIGATOR",{"type":92,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100644533","phase-1-total-intravenous-anesthesia-vs-spinal-anesthesia-in-patients-undergoing-unilateral-primary-total-knee-arthroplasty-100644533",false,"NCT07672301","Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Scheduled to undergo elective primary total knee arthroplasty (TKA) or robotic total knee arthroplasty (TKA) at the University of Chicago.\n* Eligible for same-day discharge (SDD) based on established orthopedic and anesthesia criteria.\n* Able to provide written informed consent.\n* The ability to comprehend and complete cognitive assessment surveys and questionnaires.\n* Consent to receive either Total IntraVenous Anesthesia (TIVA) or Spinal-block Anesthesia in a randomized manner\n* No contraindication to either TIVA or spinal anesthesia\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Patients undergoing revision TKA or procedures other than elective primary TKA.\n* Ineligibility for same-day discharge as determined by the surgical or anesthesia team.\n* Contraindications to either anesthetic technique (e.g., spinal block anesthesia contraindicated due to coagulopathy, infection at puncture site, or patient refusal).\n* Known allergy or hypersensitivity to study-related medications.\n* Significant pre-existing cognitive impairment or dementia that would preclude valid participation in Short Portable Mental Status Questionnaire (SPMSQ), and 3-Minute Diagnostic Assessment for Confusion Assessment Method (3D-CAM) assessments.\n* Severe chronic pain syndromes (e.g., fibromyalgia, centrally mediated pain disorders) that could confound perioperative pain assessment.\n* Body mass index (BMI) \\> 40.\n* Prisoners or other vulnerable populations unable to provide voluntary consent.\n* Unable to give appropriate consent or difficult to comprehend and complete cognitive assessment surveys and questionnaires","ALL","18 Years",{"count":102,"type":103},150,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE1","PHASE2","The purpose of this study is to compare same-day discharge rates and recovery outcomes across an adult patient population undergoing elective Total Knee Arthroplasty (TKA), and randomized to receive either spinal block anesthesia or Total IntraVenous Anesthesia (TIVA).\n\nPrimary Aim: assess same-day discharge rates between study arms (TIVA vs spinal).\n\nSecondary Aim: Postoperative comparison of recovery during PostOperative Anesthesia Care Unit (PACU) admission, diagnostic assessment scores; outcomes related to cognition, hemodynamic stability, pain, nausea and vomiting; analysis of IntraOperative electroencephalogram (EEG) monitoring metrics, e.g., total suppression time, average Bi-spectral Index monitor (BIS) value, Spectral Edge Frequency (SEF); ability for Physical Therapy (PT) evaluation prior to discharge; longterm-followup (LTFU), hospital readmission, return to surgery, etc.; adverse event (AE) monitoring.",[110],"Total Knee Arthroplasty (TKA)",[23,112,113,114],"Spinal block","Delirium - Postoperative","Postoperative Recovery","2026-06-23",{"date":117,"type":118},"2026-06-26","ACTUAL",{"date":120,"type":118},"2026-03-11",{"date":122,"type":103},"2028-06",{"name":5,"class":6},1]