Dopamine Versus Norepinephrine Under General Anesthesia

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT04536194
Collaborator
(none)
60
1
2
11.7
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease
Actual Study Start Date :
Oct 10, 2020
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. changes of cardiac index [20 minutes]

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

Secondary Outcome Measures

  1. changes of stroke volume index [20 minutes]

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

  2. 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)

  3. 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)

  4. changes of heart rate [20 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Fudan University Shanghai Shanghai China 200000

Sponsors and Collaborators

  • Children's Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhijian Zhou, vice director of department of anesthesiology, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT04536194
Other Study ID Numbers:
  • mzk-0003-2020
First Posted:
Sep 2, 2020
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhijian Zhou, vice director of department of anesthesiology, Children's Hospital of Fudan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021