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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
180
10mg of olanzapine by mouth prior to anesthetic induction
placebo by mouth prior to anesthetic induction
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Participants With Nausea and/or Vomiting
Number of participants with post-discharge nausea and/or vomiting
Time frame: in 24 hours after discharge
Number of Participants With Severe Nausea
Number of participants with severe postdischarge nausea, defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
Time frame: in 24 hours after discharge
Number of Participants With Postdischarge Vomiting
Number of participants with post discharge vomiting
Time frame: in 24 hours after discharge
Number of Participants With PONV
Number of participants with postoperative nausea and/or vomiting (PONV) in first 24 hours
Time frame: first 24 hours post-op
Number of Participants With Severe PONV
Number of participants with severe PONV in first 24 hours after post-op.defined as numerical rating scale score greater than 3. (11-point numerical rating scale from 0-10, higher score indicating worse nausea)
Time frame: first 24 hours post-op
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