Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
Condition: PONV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if subjects who receive Palonosetron plus
      Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive
      Palonosetron alone.
    

Detailed description: 
      Post-operative nausea and vomiting (PONV) is a frequent complication of surgery, with
      considerable medical and economic impact. It is also associated with high levels of patient
      discomfort and dissatisfaction. To many patients, PONV is a distressing event that reportedly
      is more feared than post-operative pain. The cause of PONV is complex and can be due to
      multiple factors. These factors may include certain characteristics of the patient (such as
      female gender, non-smoking status, and having experienced PONV in the past), the surgical
      procedure (intra-abdominal laparoscopic procedures, gynecologic surgeries, breast surgeries),
      and the type of anesthetic that is used. Untreated, the incidence of post-operative nausea
      and vomiting (PONV) in high risk patients can reach 70-80%. In addition, it is important to
      note that PONV can present during the first 24 hours after surgery or beyond. PONV alone is
      one of the leading causes for delayed discharge and unplanned hospital admission following
      outpatient surgery. Furthermore, more than 35% of surgical outpatients experience PONV
      following discharge, many of whom did not experience nausea or vomiting in the recovery room.

      An important factor in the development of Post-operative nausea and vomiting (PONV) appears
      to be the release of the biogenic amine serotonin (5-HT3) in the brainstem and the peripheral
      nervous system. Serotonin induces nausea and vomiting via the 5-HT3 receptor.

      Currently, medications that block the 5-HT3 receptor are widely accepted as a first-line
      anti-emetic in both the prevention and treatment of PONV. Ondansetron is the most commonly
      prescribed. An intra-venous dose of Ondansetron administered intra-operatively is predicted
      to reduce PONV by 15-20% when compared to patients who receive a placebo. However,
      Ondansetron has a half-life of approximately six hours and must be re-dosed in patients with
      prolonged or delayed-onset PONV.

      By contrast, Palonosetron is another 5-HT3 receptor antagonist that has a longer half-life
      than Ondansetron, thus reducing the need for re-dosing; a single dose of Palonosetron was
      shown to be superior to a single dose of Ondansetron in the treatment of delayed nausea and
      vomiting associated with chemotherapy.

      Furthermore, there is now evidence that a multimodal approach to the prevention of
      post-operative nausea and vomiting is more effective than any single medication. A recent
      study determined that a combination regimen of Ondansetron and Dexamethasone (a steroid
      medication known to prevent nausea and vomiting) provided significantly better prophylaxis
      against PONV than Ondansetron alone.

      Therefore, the rationale for conducting this study is to evaluate whether the administration
      of a single dose of Palonosetron combined with Dexamethasone is superior to a single dose of
      Palonosetron alone in the prevention of both immediate and delayed PONV in high risk patients
      undergoing laparoscopic abdominal or gynecologic surgery.

      In order to answer the question of whether Palonosetron plus Dexamethasone is significantly
      more effective at reducing the incidence of PONV than Palonosetron alone, we will enroll
      patients that are high risk for PONV who are undergoing laparoscopic abdominal or gynecologic
      surgery. This subset includes: female patients, non-smokers, and patients with a history of
      PONV.

      Each study patient will receive Palonosetron alone or Palonosetron plus Dexamethasone
      immediately prior to the start of her/his surgery. We will then use an 11 point nausea scale
      to determine how many patients had a complete response to the medication (complete response =
      NO nausea and NO vomiting at any time during the study period of 0-72 hours post surgery). If
      a patient does experience nausea or vomiting, we will record the time and severity of the
      PONV as well as whether any medication was given to relieve the nausea and vomiting. If a
      patient is discharged from the hospital before their 72nd hour post surgery, (s)he will
      receive a journal in which to record any symptoms or nausea or vomiting and a member of the
      research team will call to obtain the information.

      We predict that the combination of Palonosetron plus Dexamethasone will be superior to
      Palonosetron alone in the prevention of PONV. We will compare the incidence of patients with
      a complete response to the study medication (NO nausea and NO vomiting for 72 hours post
      surgery) to determine if this hypothesis is valid.
    

Intervention name(s): Palonosetron only; Palonosetron with Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.; Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.
Other intervention name(s): Palonosetron; Saline Solution; Palonosetron; Aloxi; Dexamethasone; Decadron
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Palonosetron; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: PONV; Outpatient surgery; Laparoscopic abdominal surgery; Laparoscopic gynecologic surgery