ISRCTN31625370已完成不适用
Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone
niversity of Leipzig (Germany)0 个研究点目标入组 3,000 人开始时间: 2005年10月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age greater than 18 years
- •2. Patient receives balanced anaesthesia (with intubation) or spinal, peridural, or combined spinal epidural anaesthesia for any of the following surgeries:
- •2.1. Hysterectomy
- •2.2. Cholecystectomy
- •2.3. Hernia repair
- •2.4. Otorhinolaryngological surgery
- •2.5. Thyroid surgery
- •2.6. Total endoprothesis of the hip or knee
- •2.7. Arthroscopy
- •3. Patient is able to answer questions regarding symptoms (taking his/her physical, emotional and mental constitution, understanding and compliance into consideration)
- •4. Informed consent in writing
排除标准
- •1. Anaesthesiological risk level of American Society of Anaesthesiologists (ASA) IV
- •2. Presence of at least one of the following cardiac risk factors:
- •2.1. Unstable angina pectoris
- •2.2. Heart failure with New York Heart Association (NYHA) greater than or equal to III and/or left ventricular ejection fraction (LVEF) less than 40%
- •2.3. Atrioventricular block grade II or III
- •3. Current treatment with any of the following:
- •3.1. Study medication
- •3.2. Other anti-emetic drugs except ranitidine
- •3.3. Selective serotonin reuptake inhibitors (SSRIs)
- •3.4. Monoamine oxidase (MAO) inhibitors
- •3.5. Tricyclic antidepressants
- •3.6. Antiarrhythmics class I or III
- •4. Disposition of the patient to malignant hyperthermia, or known occurrence thereof
- •5. History of any of the following diseases:
- •5.1. Parkinson's disease and other extrapyramidal-motoric impairment
- •5.2. Hepatic insufficiency (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] greater than 2 x upper normal value [UNV])
- •5.3. Renal insufficiency (Creatinine greater than 2 x UNV)
- •5.4. Phaeochromocytoma
- •5.5. Mechanical ileus
- •5.6. Epilepsy
- •6. Known anaphylaxis following any of the study drugs
- •7. Pregnancy or breast feeding
- •8. Participation in another therapeutic trial
- •9. Planned or foreseeable post-operative application of propofol
- •10. Planned or foreseeable post-operative artificial respiration
- •11. Planned or foreseeable leaving of a stomach tube post-operatively
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