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Not yet recruiting NCT07639723

Aprepitant to Improve Same Day Discharge for TKA

Phase IV Interventional PONV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aprepitant Injection, Ondansetron (Zofran), Dexamethasone, Placebo.
Who it may be relevant to
Registry conditions: PONV. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Preoperative Aprepitant to Improve Same-Day Discharge After Total Knee Arthroplasty: A Randomized Double-Blind Placebo-Controlled Trial

Overview

The purpose of this research is to study whether adding an FDA approved medication called aprepitant (a medication given to patients like you to reduce or eliminate nausea and vomiting) to the usual treatment to prevent nausea and vomiting given to patients during knee replacement surgery helps more patients go home on the same day of surgery (before midnight) by eliminating nausea and vomiting.

Detailed description

This is a prospective, randomized, double-blind, placebo-controlled trial involving adults undergoing primary total knee arthroplasties at Endeavor Health SKH with presumed same-day discharge (as identified by the orthopedic surgery team prior to surgery). Patients will be randomly assigned to either receive 32 mg of intravenous (IV) preoperative aprepitant, in addition to the standard antiemetic protocol (4 mg IV dexamethasone after induction of MAC sedation anesthesia and 4 mg IV ondansetron at surgical closure), or the standard protocol with placebo (saline solution in same volume at the time aprepitant is given in the preoperative holding area by nursing). Aprepitant will be administered by the preoperative nurse in the holding area to ensure blinding of the anesthesia, surgical, and postoperative teams. All patients will receive either epidural or spinal anesthesia following our standard regional anesthesia protocol, with or without an adductor canal block. Intraoperatively, all patients will receive propofol infusions titrated to a RASS of 0 to -2 per the standard of care protocol at SKH. All patients will receive postoperative rescue antiemetics as needed and within the PACU admission order set choices for PONV.

Interventions

  • Drug Aprepitant Injection
    32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy
  • Drug Ondansetron (Zofran)
    4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
  • Drug Dexamethasone
    4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
  • Other Placebo
    Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy

Primary outcome measures

  • difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care [Time frame: patients will be followed from arrival for surgery to 7 days post operatively]
Secondary outcome measures (12)
  • Rescue antiemetics [Time frame: From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first]
  • Incidence of vomiting [Time frame: Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU]
  • patients with no PONV [Time frame: arrival at hospital to post op day 7]
  • Compare the incidence of PONV in PACU and ASU [Time frame: Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU]
  • Clinically important PONV [Time frame: Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU]
  • Readmission rates [Time frame: Discharge of hospital to 7 days post operatively]
  • Postoperative Delirium Measured by 4AT Assessment [Time frame: Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).]
  • Compare APFEL Score [Time frame: Preoperatively in Holding area]
  • Compare length of stays between groups [Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)]
  • opioid consumption [Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)]
  • Patient Satisfaction [Time frame: post operative day 1 and 5]
  • Adverse Events [Time frame: These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Receiving primary, unilateral elective TKA with or without abductor canal block
  • Asa I-III
  • Age 18-90
  • Ability to receive ondansetron and dexamethasone
  • Ability to consent and complete surveys
  • English or Spanish speaking
  • Receiving regional anesthesia (epidural or spinal) for surgery

Exclusion criteria

  • Allergy to any of the anti-emetics being administered
  • Current treatment of pimozide
  • Emergent surgery
  • Revision/ multiple revisions of TKA
  • Clinical suspicion of possible bowel obstruction
  • Need for general anesthesia
  • Pregnant/breast feeding
  • AST> 2.5 x the upper limit of normal or ALT> 2.5 x upper limit of normal, bilirubin> 1.5x upper limit of normal
  • Need for opioid or benzodiazepine antagonists
  • Not planned for same day discharge
  • Enrollment in a different drug trial for TKA
  • Unable to consent in English or Spanish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Endeavor Health Skokie Hospital — Skokie

Identifiers

NCT: NCT07639723 · IRB2026-0126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗