Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Protamine Adverse Reaction

Treatments: Drug: 0.9% Normal Saline; Drug: Chlorpheniramine and ranitidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03583567

Si 2018

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

0.9% Normal Saline

Placebo Comparator group

Description:

Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL

Treatment:

Drug: 0.9% Normal Saline

Chlorpheniramine and ranitidine

Experimental group

Description:

Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)

Treatment:

Drug: Chlorpheniramine and ranitidine