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Dopamine Versus Norepinephrine Under General Anesthesia

Primary Purpose

Anesthesia, Infant, Congenital Heart Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
norepinephrine
dopamine
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring norepinephrine, dopamine

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

norepinephrine

Dopamine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

changes of stroke volume index
the differences of stroke volume index between after and before the intervention (ml/m2)
changes of systemic vascular resistance index
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
the differences of the maximal slope of systolic upstroke between after and before the intervention(mmHg/ms)
changes of heart rate
the differences of heart rate between after and before the intervention (bpm)

Full Information

First Posted
August 21, 2020
Last Updated
October 21, 2021
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04536194
Brief Title
Dopamine Versus Norepinephrine Under General Anesthesia
Official Title
Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Infant, Congenital Heart Disease, Hemodynamic Instability
Keywords
norepinephrine, dopamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
norepinephrine
Arm Type
Experimental
Arm Description
infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure
Arm Title
Dopamine
Arm Type
Active Comparator
Arm Description
infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure
Intervention Type
Drug
Intervention Name(s)
norepinephrine
Intervention Description
to treat hypotension under general anesthesia with norepinephrine
Intervention Type
Drug
Intervention Name(s)
dopamine
Intervention Description
to treat hypotension under general anesthesia with dopamine
Primary Outcome Measure Information:
Title
changes of cardiac index
Description
the differences of cardiac index between after and before the intervention (l/min/m2)
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
changes of stroke volume index
Description
the differences of stroke volume index between after and before the intervention (ml/m2)
Time Frame
20 minutes
Title
changes of systemic vascular resistance index
Description
the differences of systemic vascular resistance index between after and before the intervention(dyne ∙ sec ∙ m2/cm5)
Time Frame
20 minutes
Title
changes of the maximal slope of systolic upstroke
Description
the differences of the maximal slope of systolic upstroke between after and before the intervention(mmHg/ms)
Time Frame
20 minutes
Title
changes of heart rate
Description
the differences of heart rate between after and before the intervention (bpm)
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
share to researchers by email
Citations:
PubMed Identifier
29891225
Citation
Yuan SM. Acute kidney injury after pediatric cardiac surgery. Pediatr Neonatol. 2019 Feb;60(1):3-11. doi: 10.1016/j.pedneo.2018.03.007. Epub 2018 Mar 30.
Results Reference
background
PubMed Identifier
30613600
Citation
Foulon P, De Backer D. The hemodynamic effects of norepinephrine: far more than an increase in blood pressure! Ann Transl Med. 2018 Nov;6(Suppl 1):S25. doi: 10.21037/atm.2018.09.27. No abstract available.
Results Reference
background
PubMed Identifier
29538053
Citation
Cavigelli-Brunner A, Hug MI, Dave H, Baenziger O, Buerki C, Bettex D, Cannizzaro V, Balmer C. Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone. Pediatr Crit Care Med. 2018 Jul;19(7):619-625. doi: 10.1097/PCC.0000000000001533.
Results Reference
background
PubMed Identifier
26415680
Citation
Saxena R, Durward A, Steeley S, Murdoch IA, Tibby SM. Predicting fluid responsiveness in 100 critically ill children: the effect of baseline contractility. Intensive Care Med. 2015 Dec;41(12):2161-9. doi: 10.1007/s00134-015-4075-8. Epub 2015 Sep 28.
Results Reference
background
PubMed Identifier
29452808
Citation
Hamzaoui O, Jozwiak M, Geffriaud T, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Richard C, Teboul JL. Norepinephrine exerts an inotropic effect during the early phase of human septic shock. Br J Anaesth. 2018 Mar;120(3):517-524. doi: 10.1016/j.bja.2017.11.065. Epub 2017 Nov 21.
Results Reference
result
PubMed Identifier
27481679
Citation
Favia I, Rizza A, Garisto C, Haiberger R, Di Chiara L, Romagnoli S, Ricci Z. Cardiac index assessment by the pressure recording analytical method in infants after paediatric cardiac surgery: a pilot retrospective study. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):919-923. doi: 10.1093/icvts/ivw251. Epub 2016 Aug 1.
Results Reference
result
PubMed Identifier
25179459
Citation
Urbano J, Lopez J, Gonzalez R, Solana MJ, Fernandez SN, Bellon JM, Lopez-Herce J. Measurement of cardiac output in children by pressure-recording analytical method. Pediatr Cardiol. 2015 Feb;36(2):358-64. doi: 10.1007/s00246-014-1014-3. Epub 2014 Sep 2.
Results Reference
result
PubMed Identifier
24491036
Citation
Garisto C, Favia I, Ricci Z, Romagnoli S, Haiberger R, Polito A, Cogo P. Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery. Paediatr Anaesth. 2015 Feb;25(2):143-9. doi: 10.1111/pan.12360. Epub 2014 Feb 3.
Results Reference
result

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Dopamine Versus Norepinephrine Under General Anesthesia

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