Dopamine Versus Norepinephrine Under General Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536194
• Other study ID #: mzk-0003-2020
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Hemodynamic Instability
• Infant

Intervention

Drug:
• norepinephrine
to treat hypotension under general anesthesia with norepinephrine
• dopamine
to treat hypotension under general anesthesia with dopamine

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. 20 — View 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. — View 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.12 — View 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 — View 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. — View Citation

Urbano J, López J, González R, Solana MJ, Fernández SN, Bellón JM, López-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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of cardiac index	the differences of cardiac index between after and before the intervention (l/min/m2)	20 minutes
Secondary	changes of stroke volume index	the differences of stroke volume index between after and before the intervention (ml/m2)	20 minutes
Secondary	changes of systemic vascular resistance index	the differences of systemic vascular resistance index between after and before the intervention(dyne · sec · m2/cm5)	20 minutes
Secondary	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)	20 minutes
Secondary	changes of heart rate	the differences of heart rate between after and before the intervention (bpm)	20 minutes