Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Protamine Adverse Reaction

Intervention / Treatment
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* Drug: Chlorpheniramine and ranitidine
* Drug: 0.9% Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status 1-3 Schedule for open heart surgery Exclusion Criteria: History of allergy to the study drugs or protamine History of previous cardiac surgery or received protamine History of diabetes with insulin therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0.9% Normal Saline<br>Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL | Drug: 0.9% Normal Saline<br>* Patient will receive normal saline as placebo.<br>|
| Experimental: Chlorpheniramine and ranitidine<br>Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL) | Drug: Chlorpheniramine and ranitidine<br>* Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion. | 37 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum tryptase | Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protamine, antihistamine