Dopamine Versus Norepinephrine Under General Anesthesia

NCT04536194 | Completed Phase 3

• 1 other identifier: mzk-0003-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Infant; Congenital Heart Disease; Hemodynamic Instability

Keywords

norepinephrine; dopamine

Outcome Measures

Primary Outcomes (1)

• changes of cardiac index

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

  20 minutes

Secondary Outcomes (4)

• changes of stroke volume index

  20 minutes

• changes of systemic vascular resistance index

  20 minutes

• changes of the maximal slope of systolic upstroke

  20 minutes

• changes of heart rate

  20 minutes

Study Arms (2)

norepinephrine

EXPERIMENTAL

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

Drug: norepinephrine

Dopamine

ACTIVE COMPARATOR

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

Drug: dopamine

Interventions

norepinephrine DRUG

to treat hypotension under general anesthesia with norepinephrine

norepinephrine

dopamine DRUG

to treat hypotension under general anesthesia with dopamine

Dopamine

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• undertake cardiac surgery for congenital heart disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (8)

• 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.

  PMID: 29891225 BACKGROUND

• 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.

  PMID: 30613600 BACKGROUND

• 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.

  PMID: 29538053 BACKGROUND

• 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.

  PMID: 26415680 BACKGROUND

• 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.

  PMID: 29452808 RESULT

• 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.

  PMID: 27481679 RESULT

• 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.

  PMID: 25179459 RESULT

• 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.

  PMID: 24491036 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Norepinephrine; Dopamine

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of department of anesthesiology

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 2, 2020
• Study Start: October 10, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: share to researchers by email

Locations

CN (1)