A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Protamine remains the anticoagulant of choice for cardiopulmonary bypass (CPB). The process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. The adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. The true mechanism reaction is difficult to defined and the complexity of the clinical situation The classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction.
The reaction from pharmacologic histamine release is the most common type of reaction. Protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells From the hypothesis that the systemic hypotension cause by the released of histamine. The investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. Comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given.
There for the hypothesis of this study is administrating of H1 and H2 blocker helps attenuate the drop in MAP after protamine is given.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
normal saline will be used as placebo in control group
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1-3
- •Schedule for open heart surgery
排除标准
- •History of allergy to the study drugs or protamine
- •History of previous cardiac surgery or received protamine
- •History of diabetes with insulin therapy
研究组 & 干预措施
0.9% Normal Saline
Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL
干预措施: 0.9% Normal Saline (Drug)
Chlorpheniramine and ranitidine
Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)
干预措施: Chlorpheniramine and ranitidine (Drug)
结局指标
主要结局
Blood pressure
时间窗: 37 minutes
Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion.
次要结局
- Serum tryptase(60 minutes)
