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Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllUniversity of Chicago
NCT07672301 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.; adv

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📋 Eligibility rules (as published)
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 \<18 years. * Patients undergoing revision TKA or procedures other than elective primary TKA. * Ineligibility for same-day discharge as determined by the surgical or anesthesia team. * Contraindications to either anesthetic technique (e.g., spinal block anesthesia contraindicated due to coagulopathy, infection at puncture site, or patient refusal). * Known allergy or hypersensitivity to study-related medications. * 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. * Severe chronic pain syndromes (e.g., fibromyalgia, centrally mediated pain disorders) that could confound perioperative pain assessment. * Body mass index (BMI) \> 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
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What it tests

  • Total IntraVenous Anesthesia (TIVA)
  • Spinal-Block
  • Electroencephalogram (EEG)
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Where

1 site
University of Chicago Medical Center
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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