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Completed

NCT Number: NCT02755116

Olanzapine for Nausea After Surgery

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
  • 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.
  • 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

Treatment and study plan

Olanzapine

Drug

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

Drug

placebo by mouth prior to anesthetic induction

Primary outcomes

  1. Number of Participants With Nausea and/or Vomiting

    Time frame: in 24 hours after discharge

    Number of participants with post-discharge nausea and/or vomiting

  2. Number of Participants With Severe Nausea

    Time frame: in 24 hours after discharge

    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)

Secondary outcomes

  1. Number of Participants With Postdischarge Vomiting

    Time frame: in 24 hours after discharge

    Number of participants with post discharge vomiting

  2. Number of Participants With PONV

    Time frame: first 24 hours post-op

    Number of participants with postoperative nausea and/or vomiting (PONV) in first 24 hours

  3. Number of Participants With Severe PONV

    Time frame: first 24 hours post-op

    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)

Sponsors and collaborators

Lead sponsor

Jaime B Hyman

Other

Registry information

Official study title

Olanzapine for the Treatment of Post-Discharge Nausea and Vomiting After Ambulatory Surgery

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2016
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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