Recruiting
Phase 1
Phase 2

TIVA vs. Spinal

Sponsor:

University of Chicago

Code:

NCT07672301

Conditions

Total Knee Arthroplasty (TKA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total IntraVenous Anesthesia (TIVA)

Spinal-Block

Electroencephalogram (EEG)

Study Details

Brief 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.

Conditions

Total Knee Arthroplasty (TKA)

Study ID

NCT07672301

Start date

Mar 11, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG)

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.

active comparator: 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.

Interventions

Total IntraVenous Anesthesia (TIVA)

Total IntraVenous Anesthesia - to achieve deep-sedation via chemical analgesic (propofol, dexmedetomidine, fentanyl, hydromorphone); continuous intravenous infusion.

Spinal-Block

Spinal-block (mepivacaine 2%, 3.0 mL)

Clinician discretion to administer light-sedation with intravenously infused propofol during surgery.

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.

Primary outcome measure

  • Compare Same-Day Discharge (SDD) Rates [ Time Frame: at PostOperative (Day-0) ]

Central Contacts and Locations

Central contacts

Frank T Brown Jr, MA

773-834-5778ftbrownjr@uchicagomedicine.org

Zheng Xie, MD, PhD

773-753-1880JXie@bsd.uchicago.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Frank T Brown Jr, MA

773-834-5778ftbrownjr@uchicagomedicine.org

Zheng (Jimmy) Xie, MD, PhD

773-753-1880, pager: 1963JXie@bsd.uchicago.edu

Principal Investigator:

Zheng (Jimmy) Xie, MD, PhD

More Information

Sponsor

University of Chicago

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Total IntraVenous Anesthesia (TIVA)
  • Spinal block
  • Delirium - Postoperative
  • Postoperative Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-06-26.