Clemastine in Cardiovascular Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03826004

Enrollment

100

Registered

2019-02-01

Start date

2019-02-20

Completion date

2020-01-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy and Safety

Keywords

Cardiovascular Surgery, Histamine H1 Receptor Antagonist, Anaphylaxis

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

Interventions

DRUGSaline Solution

Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle

DRUGClemastine

Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Histamine concentration in plasma	Perioperative period	Plasma histamine concentration evaluated by ELISA

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026