Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2019-03-31

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.

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Detailed Description

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Conditions

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Protamine Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

normal saline will be used as placebo in control group

Study Groups

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0.9% Normal Saline

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

Group Type PLACEBO_COMPARATOR

0.9% Normal Saline

Intervention Type DRUG

Patient will receive normal saline as placebo.

Chlorpheniramine and ranitidine

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

Group Type EXPERIMENTAL

Chlorpheniramine and ranitidine

Intervention Type DRUG

Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.

Interventions

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0.9% Normal Saline

Patient will receive normal saline as placebo.

Intervention Type DRUG

Chlorpheniramine and ranitidine

Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No