Dopamine Versus Norepinephrine Under General Anesthesia

Phase 3

Completed

• Conditions: Congenital Heart Disease; Infant; Hemodynamic Instability; Anesthesia
• Interventions: Drug: norepinephrine; Drug: dopamine

• Registration Number: NCT04536194
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-02
• Study Start: 2020-10-10
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrine	norepinephrine	infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure
Dopamine	dopamine	infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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 stroke volume index	20 minutes	the differences of stroke volume index between after and before the intervention (ml/m2)

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China