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Taking people in United StatesPhase 1/2

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

Key facts

Who runs it
University of Chicago
Where
Chicago, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 1/2
People taking part
150 people, planned
Started
11 Mar 2026
Expected to end
Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Total IntraVenous Anesthesia (TIVA)
  • Spinal-Block
  • Electroencephalogram (EEG)
Record updated
26 June 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Age <18 years
  • Patients undergoing revision TKA or procedures other than elective primary TKA
  • 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

Where in United States

  • University of Chicago Medical CenterChicago, United StatesContact: Frank T Brown Jr, MATaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG)Existing treatment, for comparison

    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.

    Treatment: Total IntraVenous Anesthesia (TIVA) and Electroencephalogram (EEG)

  • Arm B - Spinal Block with Electroencephalogram (EEG)Existing treatment, for comparison

    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.

    Treatment: Spinal-Block and Electroencephalogram (EEG)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
26 June 2026