Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Histamine concentration in plasma
研究概览
简要总结
In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.
详细描述
In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- •Written informed consent obtained.
排除标准
- •Previous history of cardiac surgery
- •Allergy to clemastine, antihistamines with similar chemical structure or any excipient (sorbitol, sodium citrate, propylene glycol, ethanol)
- •Myasthenia gravis
- •Porphyria patients
- •Bronchial asthma
- •Usage of monoamine oxidase (MAO) inhibitors
- •Pregnant or lactating women
- •Mentally or legally disabled patients
研究组 & 干预措施
Placebo
Saline solution 2ml before anesthetic induction
干预措施: Saline Solution (Drug)
Clemastine
Clemastine fumarate 2mg/2ml before anesthetic induction
干预措施: Clemastine (Drug)
结局指标
主要结局
Histamine concentration in plasma
时间窗: Perioperative period
Plasma histamine concentration evaluated by ELISA
次要结局
- Blood pressure(Perioperative period)
- Airway pressure(Perioperative period)
- Skin manifestation(Perioperative period)
- Arrhythmia(Perioperative period)
- Specific symptoms(Perioperative period)
研究者
SHI Jia
Assoticate Professor
Chinese Academy of Medical Sciences, Fuwai Hospital