Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2019-02-20
2020-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
Saline solution 2ml before anesthetic induction
Saline Solution
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
Clemastine
Clemastine fumarate 2mg/2ml before anesthetic induction
Clemastine
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
Interventions
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Clemastine
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
Saline Solution
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
Eligibility Criteria
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Inclusion Criteria
* Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
* Written informed consent obtained.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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SHI Jia
Assoticate Professor
Principal Investigators
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Jia Shi, M.D.
Role: STUDY_CHAIR
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Locations
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Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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Clemastine Pilot Study
Identifier Type: -
Identifier Source: org_study_id
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