Dopamine Versus Norepinephrine Under General Anesthesia

Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04536194

Enrollment

Registered

2020-09-02

Start date

2020-10-10

Completion date

2021-09-30

Last updated

2021-10-22

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

Conditions

Anesthesia, Congenital Heart Disease, Hemodynamic Instability, Infant

Keywords

norepinephrine, dopamine

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.

Interventions

DRUGnorepinephrine

to treat hypotension under general anesthesia with norepinephrine

DRUGdopamine

to treat hypotension under general anesthesia with dopamine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Months

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

Design outcomes

Primary

Measure	Time frame	Description
changes of cardiac index	20 minutes	the differences of cardiac index between after and before the intervention (l/min/m2)

Secondary

Measure	Time frame	Description
changes of stroke volume index	20 minutes	the differences of stroke volume index between after and before the intervention (ml/m2)
changes of systemic vascular resistance index	20 minutes	the differences of systemic vascular resistance index between after and before the intervention(dyne ∙ sec ∙ m2/cm5)
changes of the maximal slope of systolic upstroke	20 minutes	the differences of the maximal slope of systolic upstroke between after and before the intervention(mmHg/ms)
changes of heart rate	20 minutes	the differences of heart rate between after and before the intervention (bpm)

Countries

China

Outcome results

None listed

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