The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge From Ambulatory Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
研究概览
简要总结
The primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg PO) improves quality of recovery (assessed by the Quality of Recovery-40 (QoR-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia.
The secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.
详细描述
Up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (PDNV), and PDNV represents a major barrier to improving a patient's quality of recovery. Because olanzapine has been shown to be an effective drug for PDNV prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery.
The study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at Yale New Haven Hospital. This represents the population that is most susceptible to post-discharge nausea and vomiting (PDNV) and is therefore most likely to benefit from an intervention that reduces PDNV to impact overall quality of recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female aged 18-50
- •Scheduled to undergo ambulatory surgery under general anesthesia
- •Access to smartphone device or computer with internet connection and has an email address
排除标准
- •Non-English speaking
- •Unable to swallow pills
- •Current use of anti-psychotic medications
- •History of allergy to olanzapine
- •Pregnancy/Lactation
- •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 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 < 90mmHg
- •Seizure disorder
- •Clinically active prolactinoma
- •Hepatic disease
- •Narrow angle glaucoma
- •Parkinson's disease
- •Lewy body dementia
研究组 & 干预措施
Placebo
placebo oral tablet once prior to surgery
干预措施: Placebo (Drug)
Olanzapine
olanzapine oral tablet, 5mg, once prior to surgery
干预措施: Olanzapine (Drug)
结局指标
主要结局
Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy
时间窗: post-operative day 1
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
次要结局
- Recovery Room Opioid Consumption(From surgery end time to recovery room discharge, up to 23 hours)
- Quality of Recovery-40 (QoR-40) Survey to Assess Efficacy(post-operative day 2)
- Participants With Any Nausea(post-operative day 1)
- Participants With Any Nausea(post-operative day 2)
- Number of Participants With Severe Post-discharge Nausea(up to 24 hours post discharge)
- Recovery Room Length of Stay(From surgery end time to recovery room discharge, up to 23 hours)
研究者
Jaime B. Hyman, MD
Associate Professor of Anesthesiology
Yale University