Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the efficacy and safety of adding transdermal
      preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting
      (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the
      previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing
      surgical procedure under general anesthesia.

      The specific aims of the study include:

        1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery

        2. incidence and seriousness of the observed side effects

        3. ability of patients to self-administer preoperatively and maintain the investigated
           patch during the perioperative period

        4. level of satisfaction with the preoperative PONV prophylaxis.
    

Detailed description: 
      Patients will be recruited from the surgical population undergoing preoperative evaluation in
      Anesthesiology Preoperative Evaluation Clinic at Hershey Med. Ctr. (~15,000 per year).
      Selected patients (ASA 1-3, N=60) with history of severe PONV after one or more of previous
      general anesthesia, and scheduled to undergo surgical procedures with general anesthesia will
      be enrolled into IRB approved protocol. The patch will be placed by the patient at home 24 -
      48 hours before surgery as directed by the doctor. The subsequent standardized general
      anesthesia protocol for elective surgery will include general endotracheal anesthesia with
      sevofluran, including standard intraoperative PONV prophylaxis (IV dexamethasone and IV
      ondansetron, each 4 mg). Postoperative evaluation will include recording of incidence and
      severity of PONV at the time of discharge from PACU (acute PONV), at 24 hr, 48 hrs, 72 and
      120 hrs (delayed or post discharge PONV).

      7.2.1 Visit 1 - Anesthesia Preoperative Evaluation Clinic and recruitment and drug
      dispensation Patient is seen in clinic and identified as having a history of serious PONV, in
      particular delayed or post discharge PONV. Study will be explained to the patient and consent
      obtained. The investigational pharmacy will be notified that a study patient has been
      enrolled and they will prepare the patches for distribution to the patient.

      A member of the research team will obtain the assigned patches from the investigational
      pharmacy and deliver to the anesthesia provider (member of the research team).

      The provider will then demonstrate to the patient how to apply the patch and the patient can
      practice using a placebo patch to show that the correct placement. Patient will then take the
      actual patch home with them.

      7.2.2 Visit 2 - approximately 24-48 hours preoperatively (patient's home) Patient will apply
      the patch to their upper arm 24-48 hours before scheduled surgical procedure, as instructed
      during their pre-op anesthesia visit. The patch will then remain in place until 120 hours
      after surgical procedure. No backup patch will be provided so the patients with the
      accidently missing patch will need to call their primary surgical service for the standard
      antiemetic medication.

      7.2.3 Visit 3- Day of Surgery Patient will arrive for surgery. A member of the research team
      will meet them in the SDU and record the time that the patch was applied, and if it has been
      placed correctly, intact and still in place. Any potential side effects (systemic or local)
      will be recorded at that time. The subsequent standardized general anesthesia protocol for
      elective surgery will include general endotracheal anesthesia with sevofluran (no nitrous
      oxide), muscle relaxants (with reversal), intraoperative IV opioid analgesics, including
      standard PONV prophylaxis (dexamethasone and ondansetron IV 4 mg).

      Early postoperative evaluation will include recording of incidence and severity of PONV at
      the time of discharge from PACU (acute PONV). The incidence of vomiting or retching will
      recorded by the nursing staff. Patients with symptoms requiring a rescue antiemetic-nausea
      score ≥4 on an 11-point Numeric Rating Scale (NRS), retching or vomiting, or patient
      request-within 6 hours of PACU admission will be given the rescue medication (Benadryl or
      promethazine). The NRS was an 11-point linear scale on which patients rated their nausea,
      with 0 meaning no nausea and 10 meaning the worst possible nausea.

      The subsequent evaluations will be performed either at the patient's bed (if in the hospital)
      or by phone call at 24 hr, 48 hrs, 72 and 120 hrs (delayed or post discharge PONV). The
      patient will be supplied with a diary to record the information that will be requested on the
      follow-up phone calls.

      The primary efficacy endpoint will be complete response (CR), defined as no emetic episode
      and no rescue medication; the proportions of patients with no emesis and no additional rescue
      medication in the 120 hours following the completion of surgical procedure and the change
      from baseline nausea score using the NRS. Treatment-emergent adverse events (TEAEs),
      regardless of suspected causal relationship to the study medication, will be also recorded
      throughout and continued until 5 days after surgery.

      7.3 Duration of Participation Patient will remain in the study until all time points have
      been met (maximum 5 days following surgery or 120 hours). At the end of the study the patient
      will remove and dispose the remaining patch.
    

Intervention name(s): granisetron
Intervention type(s): Drug
Intervention description(s): Application granisetron transdermal patch preoperatively
Other intervention name(s): Sancuso
Intervention MeSH terms: Granisetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PONV; anesthesia; granisetron