Health TrialsbyHealthPanel

Aprepitant to Improve Same Day Discharge for TKA

ConditionPONV
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorEndeavor Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Receiving primary, unilateral elective TKA with or without abductor canal block

Asa I-III

Age 18-90

Ability to receive ondansetron and dexamethasone

Disqualifiers

Allergy to any of the anti-emetics being administered

Current treatment of pimozide

Emergent surgery

Revision/ multiple revisions of TKA

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aprepitant Injection

    Drug

    32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy

  • Ondansetron (Zofran)

    Drug

    4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy

  • Dexamethasone

    Drug

    4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy

  • Placebo

    Other intervention

    Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: aprepitantExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endeavor Health

Lead sponsor

Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: