An interventional study of Clemastine and Saline Solution in Efficacy and Safety, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Prevention
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.
Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Saline solution 2ml before anesthetic induction
Drug: Saline Solution
Clemastine fumarate 2mg/2ml before anesthetic induction
Drug: Clemastine
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
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
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital