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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
Histamine concentration in plasma
Plasma histamine concentration evaluated by ELISA
Time frame: Perioperative period
Blood pressure
Invasive blood pressure of radial artery: systolic, diastolic and mean pressure
Time frame: Perioperative period
Airway pressure
Airway pressure: peak and plat
Time frame: Perioperative period
Skin manifestation
Rate of skin manifestations, including wheal, papules, maculopapules, etc
Time frame: Perioperative period
Arrhythmia
Rate of perioperative arrhythmia, especially tachycardia
Time frame: Perioperative period
Specific symptoms
Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth
Time frame: Perioperative period
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