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临床试验/NCT02755116
NCT02755116已完成2 期

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

Jaime B Hyman1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Number of Participants With Nausea and/or Vomiting

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adults age ≥ 18 and ≤ 50 years old
  • Patient scheduled to undergo ambulatory surgery under general anesthesia
  • Willing and able to provide informed consent

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

Olanzapine

Experimental

10mg pill

干预措施: Olanzapine (Drug)

结局指标

主要结局

Number of Participants With Nausea and/or Vomiting

时间窗: in 24 hours after discharge

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

Number of Participants With Severe Nausea

时间窗: 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)

次要结局

  • Number of Participants With Postdischarge Vomiting(in 24 hours after discharge)
  • Number of Participants With Severe PONV(first 24 hours post-op)
  • Number of Participants With PONV(first 24 hours post-op)

研究者

发起方
Jaime B Hyman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jaime B Hyman

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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