MedDataX Logo

Dopamine Versus Norepinephrine Under General Anesthesia

NCT ID: NCT04536194

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Infant Congenital Heart Disease Hemodynamic Instability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

norepinephrine

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

Group Type EXPERIMENTAL

norepinephrine

Intervention Type DRUG

to treat hypotension under general anesthesia with norepinephrine

Dopamine

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

Group Type ACTIVE_COMPARATOR

dopamine

Intervention Type DRUG

to treat hypotension under general anesthesia with dopamine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

norepinephrine

to treat hypotension under general anesthesia with norepinephrine

Intervention Type DRUG

dopamine

to treat hypotension under general anesthesia with dopamine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhijian Zhou

vice director of department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29891225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30613600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29538053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26415680 (View on PubMed)

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.

Reference Type RESULT
PMID: 29452808 (View on PubMed)

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.

Reference Type RESULT
PMID: 27481679 (View on PubMed)

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.

Reference Type RESULT
PMID: 25179459 (View on PubMed)

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.

Reference Type RESULT
PMID: 24491036 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

mzk-0003-2020

Identifier Type: -

Identifier Source: org_study_id