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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07672301). StuddyBuddy aggregates publicly available trial information.