Clemastine in Cardiovascular Surgery

Not Applicable

Completed

• Conditions: Efficacy and Safety
• Interventions: Drug: Saline Solution; Drug: Clemastine

• Registration Number: NCT03826004
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-02-20
• Primary Completion: 2019-07-31
• Status Verified: 2020-01
• Study Completion: 2020-01-10
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline Solution	Saline solution 2ml before anesthetic induction
Clemastine	Clemastine	Clemastine fumarate 2mg/2ml before anesthetic induction

Primary Outcome Measures

Name	Time	Method
Histamine concentration in plasma	Perioperative period	Plasma histamine concentration evaluated by ELISA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, Beijing, China