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Recruiting
NCT07672301
Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty
Conditions: Total Knee Arthroplasty (TKA)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 150
Sponsor: University of Chicago
Location: University of Chicago Medical Center Chicago Illinois
Summary
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).
Primary Aim: assess same-day discharge rates between study arms (TIVA vs spinal).
Secondary 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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged ≥18 years.
* Scheduled to undergo elective primary total knee arthroplasty (TKA) or robotic total knee arthroplasty (TKA) at the University of Chicago.
* Eligible for same-day discharge (SDD) based on established orthopedic and anesthesia criteria.
* Able to provide written informed consent.
* The ability to comprehend and complete cognitive assessment surveys and questionnaires.
* Consent to receive either Total IntraVenous Anesthesia (TIVA) or Spinal-block Anesthesia in a randomized manner
* No contraindication to either TIVA or spinal anesthesia
Exclusion Criteria:
* Age \ 40.
* Prisoners or other vulnerable populations unable to provide voluntary consent.
* Unable to give appropriate consent or difficult to comprehend and complete cognitive assessment surveys and questionnaires
Source: ClinicalTrials.gov (NCT07672301). StuddyBuddy aggregates publicly available trial information.