Clinical trial NCT04536194: Dopamine Versus Norepinephrine Under General Anesthesia
Official title: Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Infant
Congenital Heart Disease
Hemodynamic Instability
Keywords: norepinephrine
dopamine
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.

Detailed description: After intubation under general anesthesia, radial arterial is cannulated and pressure transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean arterial pressure. Changes of these hemodynamic data are compared.

Eligibility criteria: Inclusion Criteria:

* undertake cardiac surgery for congenital heart disease

Exclusion Criteria:

* Aortic valve or aortic disease
* severe arrhythmia
* use of cardiovascular active drugs before anesthesia
* need to use a combination of different cardiovascular support drugs after anesthesia

Primary outcomes:
measure: changes of cardiac index
timeFrame: 20 minutes
Secondary outcomes:
measure: changes of stroke volume index
timeFrame: 20 minutes
measure: changes of systemic vascular resistance index
timeFrame: 20 minutes
measure: changes of the maximal slope of systolic upstroke
timeFrame: 20 minutes
measure: changes of heart rate
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
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