Olanzapine for Nausea After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02755116
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Jaime B Hyman, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Olanzapine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Olanzapine for the Treatment of Post-Discharge Nausea and Vomiting After Ambulatory Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Olanzapine
10mg pill
Drug: Olanzapine
10mg of olanzapine by mouth prior to anesthetic induction
Other Names:
  • Zyprexa
  • 132539-06-1
  • Zyprexa Zydis
  • Olansek
  • Symbyax2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine
Placebo Comparator: Placebo Drug: Placebo
placebo by mouth prior to anesthetic induction

Primary Outcome Measures :
  1. Incidence of Nausea [ Time Frame: up to 24 hours ]
    Rate of post-discharge nausea

  2. Incidence of Vomiting [ Time Frame: up to 24 hours ]
    Rate of post-discharge retching/vomiting

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02755116

Contact: Jaime B Hyman, MD 212-241-7749
Contact: Samuel Demaria, MD 212-241-7749

United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Jaime Hyman, MD         
Sponsors and Collaborators
Jaime B Hyman
Principal Investigator: Jaime B Hyman, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Jaime B Hyman, Assistant Professor, Icahn School of Medicine at Mount Sinai Identifier: NCT02755116     History of Changes
Other Study ID Numbers: GCO 15-1297
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jaime B Hyman, Icahn School of Medicine at Mount Sinai:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents