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

NCT07672301 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: IRB25-1483
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Compare Same-Day Discharge (SDD) Rates

  Comparison of same-day discharge rates between patients receiving either total intravenous anesthesia (TIVA) or spinal-block anesthesia, during total knee arthroplasty (TKA).

  at PostOperative (Day-0)

Secondary Outcomes (9)

• Post-Anesthesia Care Unit (PACU) Length of Admission

  at PostOperative (Day-0)

• Changes in Short Portable Mental Status Questionnaire (SPMSQ)

  at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)

• Changes in 3-Minute Diagnostic Assessment for Confusion Assessment Method (3D-CAM)

  at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)

• Changes in Numeric Rating Scale (NRS) score, Nausea

  at PostOperative (Day-0) and PostOperative (Day-1)

• Monitor changes in Numeric Pain Rating Scale (NPRS) score

  at PostOperative (Day-0) and PostOperative (Day-1)

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Combination Product: Total IntraVenous Anesthesia (TIVA); Device: Electroencephalogram (EEG)

Arm B - Spinal Block with Electroencephalogram (EEG)

ACTIVE COMPARATOR

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.

Combination Product: Spinal-Block; Device: Electroencephalogram (EEG)

Interventions

Total IntraVenous Anesthesia (TIVA) COMBINATION_PRODUCT

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

Also known as: General Anesthesia, Systemic Anesthesia, TIVA, Deep Sedation

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

Spinal-Block COMBINATION_PRODUCT

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

Also known as: Regional Anesthesia, Nerve-Block, Field-Block, Local Anesthesia, Light Sedation

Arm B - Spinal Block with Electroencephalogram (EEG)

Electroencephalogram (EEG) DEVICE

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.

Also known as: EEG, Bi-spectral Index monitor (BIS), BIS, Brain Monitoring, Neurological (Neuro) Monitoring

Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG); Arm B - Spinal Block with Electroencephalogram (EEG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Anesthesia, General; Deep Sedation; Anesthesia, Spinal; Anesthesia, Conduction; Nerve Block; Anesthesia, Local; Electroencephalography

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Zheng Xie, MD, PhD

  University of Chicago, Department of Anesthesia and Critical Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank T Brown Jr, MA

CONTACT

773-834-5778; ftbrownjr@uchicagomedicine.org

Zheng Xie, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, multiple-arm comparison (66-evaluable, Total intravenous anesthesia vs 66-evaluable Spinal-block).

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 26, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: De-identified data may be shared adhoc at the discretion of the principal investigator, following completion of study enrollment and data analysis.
• Access Criteria: Only researchers and statisticians at the University of Chicago may have access to any shared de-identified study data.

Locations

US (1)