NCT07672301 Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty
| NCT ID | NCT07672301 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Chicago |
| Condition | Total Knee Arthroplasty (TKA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2026-03-11 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Zheng Xie, MD, PhD
PRINCIPAL INVESTIGATOR
University of Chicago, Department of Anesthesia and Critical Care
Frequently Asked Questions
Who can join the NCT07672301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty (TKA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07672301 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07672301 currently recruiting?
Yes, NCT07672301 is actively recruiting participants. Contact the research team at ftbrownjr@uchicagomedicine.org for enrollment information.
Where is the NCT07672301 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07672301 clinical trial?
NCT07672301 is sponsored by University of Chicago. The principal investigator is Zheng Xie, MD, PhD at University of Chicago, Department of Anesthesia and Critical Care. The trial plans to enroll 150 participants.