A Phase 4 interventional study of Aprepitant Injection and Ondansetron (Zofran) in PONV, sponsored by Endeavor Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Endeavor Health · Phase 4, Interventional, and Prevention
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.
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.
609 studies on the registry are indexed under Postoperative Nausea and Vomiting; 109 are open to participants now.
This study's planned enrollment of 350 is above the median of 113 across 508 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
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Exclusion Criteria:
Single intravenous (IV) bolus of 32mg aprepitant preoperatively , 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)
Drug: Aprepitant Injection · Drug: Ondansetron (Zofran) · Drug: Dexamethasone
Single intravenous (IV) bolus of 32mg of placebo preoperatively, 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)
Drug: Ondansetron (Zofran) · Drug: Dexamethasone · Other: Placebo
32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy
4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy
difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care
difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care. Subjects will be randomized to either the aprepitant group (administration of aprepitant, ondansetron, and dexamethasone) or control (ondansetron, dexamethasone, and placebo). PACU and ASU staff will collect real time data with regard to the primary and secondary reason for any hospital admission (PONV, Pain control, Rapid response team called, Vital sign abnormalities, Change in mental status, Other). Same day discharge will be defined by patients who are discharged from the hospital before 12 A.M day of surgery. We will use the validated simplified PONV Impact Scale that uses patient assessment of nausea and vomiting to identify clinically important PONV upon PACU and ASU discharge (a PONV impact scale score of greater than or equal to 5 defines clinically important PONV).
Time frame: patients will be followed from arrival for surgery to 7 days post operatively
Rescue antiemetics
Compare rescue antiemetics doses and counts given during the hospital stay in each group.
Time frame: From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first
Incidence of vomiting
Compare the incidence of vomiting between both groups in PACU and ASU (None = No PONV symptoms, Mild = Patient feels queasy but is able to take PO, will treat with alcohol pads and/or QueaseEASE, Moderate = Patient is unable to take PO and is restless, will treat with rescue antiemetics per standard PACU orderset, Severe = Actively vomiting, will treat with rescue antiemetics per standard PACU orderset)
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
Compare the number of patients in each group who experience no PONV.
Time frame: arrival at hospital to post op day 7
Compare the incidence of PONV in PACU and ASU
Compare the incidence of PONV between both groups in PACU and ASU using Endeavor Health SKH PACU PONV assessment scales, and stratify both groups by none, mild, moderate, and severe PONV (None = No PONV symptoms, Mild = Patient feels queasy but is able to take PO, will treat with alcohol pads and/or QueaseEASE, Moderate = Patient is unable to take PO and is restless, will treat with rescue antiemetics per standard PACU orderset, Severe = Actively vomiting, will treat with rescue antiemetics per standard PACU orderset)
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
Compare the incidence of clinically important PONV between both groups in PACU and ASU using the validated simplified PONV Impact Scale. a PONV impact scale score of greater than or equal to 5 defines 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
Compare readmission rates within 7 days postoperatively, stratified by admissions due to nausea/vomiting or related complications, and those for other medical or surgical reasons.
Time frame: Discharge of hospital to 7 days post operatively
Postoperative Delirium Measured by 4AT Assessment
Compare incidence of delirium in both groups. Delirium will be detected using the 4AT validated survey upon PACU discharge compared to a preoperative baseline assessment Preoperative baseline
Time frame: Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).
Compare APFEL Score
Compare Apfel Scores for Postoperative Nausea and Vomiting in both groups (determined preoperatively in holding area by research team) . Apfel score is a quick, validated clinical tool used by anesthesiologists to predict a patient's risk of developing Postoperative Nausea and Vomiting (PONV).The total score (0-4) predicts the percentage risk of developing PONV
Time frame: Preoperatively in Holding area
Compare length of stays between groups
Compare PACU length of stay (hours) and hospital length of stay (hours) between groups.
Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
opioid consumption
Compare opioid consumption in morphine milligram equivalents (MMEs) between groups intraoperatively, in PACU, and during the total hospital period.
Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction
Compare patient satisfaction scores using a Likert scale on postoperative days 1 and 5. "The anesthesia care I received during my total knee arthroplasty (TKA) procedure met my expectations" (5= strongly agree, 1=strongly disagree) and "The management of any nausea and vomiting following my total knee arthroplasty (TKA) procedure met my expectations" (5= strongly agree, 1=strongly disagree).
Time frame: post operative day 1 and 5
Adverse Events
Compare the adverse events that could be related to aprepitant vs. placebo between groups. These events may include but are not limited to: injection site reactions, hypersensitivity reactions or skin reactions, abdominal discomfort, constipation or diarrhea, dizziness, hiccups, headache
Time frame: These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively
Plan to share: No — Individual participant data will not be shared due to institutional policies and to protect participant privacy.
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