Dopamine Versus Norepinephrine Under General Anesthesia

Fudan University

Status and phase: Completed; Phase 3

Conditions: Hemodynamic Instability; Infant; Congenital Heart Disease; Anesthesia

Treatments: Drug: dopamine; Drug: norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04536194

mzk-0003-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

norepinephrine

Experimental group

Description:

infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure

Treatment:

Drug: norepinephrine

Dopamine

Active Comparator group

Description:

infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure

Treatment:

Drug: dopamine