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临床试验/NCT07672301
NCT07672301招募中1 期

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

University of Chicago1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年3月11日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
150
试验地点
1
主要终点
Compare Same-Day Discharge (SDD) Rates

研究概览

简要总结

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.

详细描述

Same-day discharge after total knee arthroplasty (TKA) has become a central goal within Enhanced Recovery After Surgery (ERAS) protocols, particularly in large academic centers. Spinal anesthesia is widely used in this setting and offers advantages through avoidance of general anesthesia-related risks, including airway instrumentation and systemic anesthetic exposure; however, spinal anesthesia may also be associated with prolonged motor blockade, urinary retention, and delayed mobilization, which can hinder same-day discharge in some patients. Rare risks include headache (sometimes called a spinal headache), back soreness, the numbness spreading too high, or the spinal not working well enough and needing conversion to general anesthesia. Very rare but serious risks include infection, bleeding around the spinal cord, or nerve injury.

Total intravenous anesthesia (TIVA) represents an alternative approach that avoids neuraxial anesthesia and its associated risks, including motor weakness and urinary retention, and may reduce postoperative nausea and vomiting. However, TIVA typically requires airway instrumentation and exposure to general anesthetic agents, which carry risks such as sore throat, airway-related discomfort, dental trauma, and potential concerns regarding anesthetic dosing and recovery, particularly in older adults. Processed EEG-guided anesthesia has been proposed as a strategy to optimize anesthetic depth during general anesthesia and potentially reduce overdosing, though its impact on recovery outcomes within contemporary ERAS pathways remains incompletely defined.

This research will address this knowledge gap through a prospective, randomized trial. By comparing same-day discharge rates as the primary outcome-and examining recovery efficiency, postoperative complications, cognitive outcomes, and patient satisfaction as secondary and exploratory measures-this study will provide foundational evidence to inform anesthetic selection. Ultimately, these findings have the potential to refine perioperative care, optimize recovery, and inform future definitive trials and clinical practice guidelines for TKA, improving outcomes for a growing elderly surgical population.

A study comparison of the two anesthesia techniques (TIVA vs spinal-block) in patients undergoing total knee arthroplasty (TKA) is appropriate because anesthetic choice directly influences perioperative recovery, same-day discharge rates, and patient-centered outcomes. Total Knee Arthroplasty (TKA) represents one of the most common and rapidly increasing elective procedures worldwide, particularly among the elderly population at higher risk for adverse outcomes and longer postoperative recovery. A prospective, randomized study design allows for a controlled comparison of the two widely utilized anesthetic techniques within the context of modern ERAS protocols, while also incorporating standardized follow-up to capture both short-term and 90-day long-term outcomes. Beyond individual patient recovery, this research carries broader public health implications: with an aging population and rising demand for TKA, optimizing perioperative pathways that enhance recovery, reduce complications, and support same-day discharge has the potential to decrease healthcare utilization, lower costs, and improve the sustainability of orthopedic care delivery.

Based on our experience caring of these patients over the years, patients with strong preferences or contradictions to one of the two approaches are relatively small (~10-15%). Most patients defer to their anesthesiologists and surgeons to provide the best care plan for them. In the current practice, both anesthesia approaches are widely acceptable care for most patients undergoing TKA and no clear advantages in risk/benefit ratio in same day discharge between methods of anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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) >
  • 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

结局指标

主要结局

Compare Same-Day Discharge (SDD) Rates

时间窗: at PostOperative (Day-0)

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

次要结局

  • Changes in IntraOperative electroencephalogram (EEG) monitoring(IntraOperative)
  • Satisfaction-Numeric Rating Scale (NRS) score(at PostOperative (Day-0) and PostOperative (Day-1))
  • 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))
  • Adverse Event (AE) monitoring(PeriProcedural to Study Completion)
  • Longterm-Followup (LTFU), Outcomes(at PostOperative (Day-90))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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