Clemastine in Cardiovascular Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study

Conditions
-----------------
Efficacy and Safety

Intervention / Treatment
-----------------
* Drug: Clemastine
* Drug: Saline Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease Written informed consent obtained. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline solution 2ml before anesthetic induction | Drug: Saline Solution<br>* Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle<br>|
| Experimental: Clemastine<br>Clemastine fumarate 2mg/2ml before anesthetic induction | Drug: Clemastine<br>* Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histamine concentration in plasma | Plasma histamine concentration evaluated by ELISA | Perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Invasive blood pressure of radial artery: systolic, diastolic and mean pressure | Perioperative period | 
| Airway pressure | Airway pressure: peak and plat | Perioperative period | 
| Skin manifestation | Rate of skin manifestations, including wheal, papules, maculopapules, etc | Perioperative period | 
| Arrhythmia | Rate of perioperative arrhythmia, especially tachycardia | Perioperative period | 
| Specific symptoms | Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth | Perioperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Surgery, Histamine H1 Receptor Antagonist, Anaphylaxis