Dopamine Versus Norepinephrine Under General Anesthesia

October 21, 2021 updated by: Zhijian Zhou, Children's Hospital of Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: norepinephrine
infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure
Drug: norepinephrine
to treat hypotension under general anesthesia with norepinephrine
Active Comparator: Dopamine
infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure
Drug: dopamine
to treat hypotension under general anesthesia with dopamine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of stroke volume index
Time Frame: 20 minutes
the differences of stroke volume index between after and before the intervention (ml/m2)
20 minutes
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)
20 minutes
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)
20 minutes
changes of heart rate
Time Frame: 20 minutes
the differences of heart rate between after and before the intervention (bpm)
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mzk-0003-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

share to researchers by email

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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