Olanzapine for Nausea After Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Olanzapine; Placebo
Intervention description: 10mg of olanzapine by mouth prior to anesthetic induction; placebo by mouth prior to anesthetic induction
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Nausea; Vomiting

Summary:

      Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic
      techniques have improved and pressure to reduce health-care costs has increased. While there
      are many benefits to recovering from surgery within the home, a significant disadvantage is
      the lack of rapid access to a healthcare provider when postoperative complications occur.
      Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent
      studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after
      ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years,
      history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in
      the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in
      the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative
      ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to
      prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the
      incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel
      strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be
      administered preoperatively. This study will evaluate whether there is a difference in the
      incidence and severity of PDNV between patients who receive oral olanzapine versus placebo
      prior to general anesthesia for ambulatory surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age ≥ 18 and ≤ 50 years old

          -  Patient scheduled to undergo ambulatory surgery under general anesthesia

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Unable to swallow pills

          -  Current use of typical or atypical anti-psychotic medications

          -  History of allergy to olanzapine

          -  Pregnancy/Lactation (subjects of child-bearing potential will have a urine pregnancy
             test performed the day of surgery)

          -  History of QTc > 450ms or torsades de pointes

          -  Current use of antihypertensive medication

          -  Diabetes Mellitus

          -  Clinically significant cardiovascular disease defined as follows:

               1. Myocardial infarction or unstable angina within 6 months prior to the day of
                  planned surgery.

               2. History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or
                  ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic
                  medications, except for atrial fibrillation that is well controlled on
                  anti-arrhythmic medication.

               3. New York Heart Association (NYHA) Class II or higher congestive heart failure.

          -  Postural hypotension or vasovagal syncope within 6 months of planned surgery.

          -  Hypotension on day of surgery, defined as a systolic blood pressure < 90mm Hg or a
             diastolic pressure < 60mm Hg.

          -  Seizure disorder

          -  Clinically active prolactinoma

          -  Hepatic disease

          -  Poorly controlled diabetes

          -  Pre-operative blood glucose > 250 mg/dL

          -  Narrow angle glaucoma

          -  Parkinson's disease

          -  Lewy body dementia