Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- akathisia and nausea scores
研究概览
简要总结
Study Objective:
The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia.
Methods:
This was a prospective, randomized, double-blind trial. The investigation was held between 01 March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of Medicine. The patients with moderate to severe nausea randomized and divided into two groups as for the previously planned administration type of drug. Ten mg metoclopramide was administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea scores and vital changes were recorded.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study.
- •Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems.
排除标准
- •Patients with mild symptoms of nausea
- •Altered mental status
- •Abnormal vital signs
- •Any known allergy to the metoclopramide
- •Previously enrolled in the study
- •Known renal failure or insufficiency
- •GIS hemorrhage, ileus and/or perforation
- •Women who were pregnant and lactating
- •Those with a history of epilepsy
- •Admitted to the ED due to acute psychiatric symptoms
- •Restless legs syndrome
- •Parkinson
- •Organic brain disease
- •Phaeochromocytoma
- •Patient with alcohol
- •Anticholinergic, sedative, hypnotic, trankilizan, digoxin, cimetidine, tetracycline and levo-dopa use
- •Presence of severe agitation akathisia can not be evaluated and uncooperative individuals.
研究组 & 干预措施
2 minutes bolus infusion
干预措施: metoclopramide 10 mg (Drug)
15 minutes slow infusion
干预措施: metoclopramide 10 mg (Drug)
结局指标
主要结局
akathisia and nausea scores
次要结局
未报告次要终点