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RECRUITING
NCT07672301
PHASE1/PHASE2

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

Sponsor: University of Chicago

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-03-11

Completion Date

2028-06

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Total IntraVenous Anesthesia (TIVA)

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

COMBINATION_PRODUCT

Spinal-Block

Spinal-block (mepivacaine 2%, 3.0 mL) Clinician discretion to administer light-sedation with intravenously infused propofol during surgery.

DEVICE

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.

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States