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Completed

NCT Number: NCT04536194

Dopamine Versus Norepinephrine Under General Anesthesia

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.

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Key information

Conditions

Anesthesia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hemodynamic Instability Infant

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

to treat hypotension under general anesthesia with norepinephrine

Dopamine

Drug

to treat hypotension under general anesthesia with dopamine

Primary outcomes

  1. changes of cardiac index

    Time frame: 20 minutes

    the differences of cardiac index between after and before the intervention (l/min/m2)

Secondary outcomes

  1. changes of stroke volume index

    Time frame: 20 minutes

    the differences of stroke volume index between after and before the intervention (ml/m2)

  2. changes of systemic vascular resistance index

    Time frame: 20 minutes

    the differences of systemic vascular resistance index between after and before the intervention(dyne ∙ sec ∙ m2/cm5)

  3. changes of the maximal slope of systolic upstroke

    Time frame: 20 minutes

    the differences of the maximal slope of systolic upstroke between after and before the intervention(mmHg/ms)

  4. changes of heart rate

    Time frame: 20 minutes

    the differences of heart rate between after and before the intervention (bpm)

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2020
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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