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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total IntraVenous Anesthesia (TIVA)

    Combination product

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

  • Spinal-Block

    Combination product

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

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG)Active comparator 2 interventions
Group B: Arm B - Spinal Block with Electroencephalogram (EEG)Active comparator 2 interventions

Trial outcomes

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).

Time frame
at PostOperative (Day-0)

Secondary outcomes

1

Post-Anesthesia Care Unit (PACU) Length of Admission

PostOperative comparison of post-anesthesia care unit (PACU) length of stay (LOS), between both study arms (TIVA vs Spinal-block). Exact Time Recorded: at PACU admission, physical therapy evaluation, diagnostic survey assessment completion, and at discharge home. Study-arm timepoints range are averaged and compared.

Time frame
at PostOperative (Day-0)
2

Changes in Short Portable Mental Status Questionnaire (SPMSQ)

The Short Portable Mental Status Questionnaire (SPMSQ) is an interview based validated diagnostic, evaluating basic orientation, memory, current events, and mathematical capabilities (such as counting backward) to determine if a patient requires further, more extensive neurological evaluation. SPMSQ: 10-question bank SPMSQ Calculation: First - subtract incorrect responses from correct Second - allow for one more error in the scoring if a patient has had a grade school education or less; or one less error if the patient has had education beyond the high school level. Third - calculate outcome associated with number of errors: 0-2 = normal mental functioning 3-4 = mild cognitive impairment 5-7 = moderate cognitive impairment 8 or more errors: severe cognitive impairment

Time frame
at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)
3

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

3D-CAM is an interview based bedside tool, screening for, four cardinal features of delirium (i.e., acute changes, inattention, disorganized thinking, altered level of consciousness) 3D-CAM: Patient Interview (10 items): provider asks the patient questions to gauge orientation and attention (e.g., reciting numbers backwards, months of the year backwards, and simple orientation questions) Observer Ratings (10-12 items): provider records clinical observations and asks collateral sources (family members, nurses, or caregivers) about any sudden changes in the patient's mental status from their baseline 0-20 Scale (Total Score): clinician evaluates cognitive and behavioral items, points are assigned for each positive item, resulting in a score between 0 and 20 Severity Bands: a score of 0 to 1 indicates normal/no delirium, while 2 to 20 indicates increasing levels of delirium severity (subsyndromal to severe delirium)

Time frame
at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)
4

Changes in Numeric Rating Scale (NRS) score, Nausea

Nausea, Numeric Rating Scale (NRS), patient-reported diagnostic to evaluate severity of nausea. Patient rating using a single whole integer from 0 to 10 that best reflects the level nausea. Nausea NRS rated on a scale from 0 to 10 (where 0 means no nausea and 10 means the worst possible nausea).

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

Other outcomes

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