NCT03366597

Brief Summary

To observe the effect of sevoflurane on the concentration of S100β and regional cerebral oxygen saturation in infants with congenital heart disease undergoing cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3.9 years

First QC Date

November 21, 2017

Last Update Submit

February 9, 2021

Conditions

Congenital Heart DiseaseInfant, Premature, Diseases

Keywords

sevofluraneS100β proteinregional cerebral oxygen saturationinfant

Outcome Measures

Primary Outcomes (1)

  • Concentration of S100β protein

    The concentration of S100β protein was performed using the electrochemiluminescence immunoassay.(Blood samples from patients were drawn from central intravenous.)

    5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative

Secondary Outcomes (1)

  • Level of regional cerebral oxygen saturation(rScO2)

    5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative

Study Arms (1)

Sevoflurane

EXPERIMENTAL

Sevoflurane will be used as a narcotic drug in one group during cardiac surgery.

Drug: Sevoflurane

Interventions

SevofluraneDRUG

1.5%-3% Sevoflurane will be given during the cardiac surgery except cardiopulmonary bypass.

Sevoflurane

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of congenital heart disease
  • Undergoing heart surgery with cardiopulmonary bypass

You may not qualify if:

  • Pulmonary arterial hypertension
  • Sevoflurane allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Related Publications (5)

  • Fenton KN, Freeman K, Glogowski K, Fogg S, Duncan KF. The significance of baseline cerebral oxygen saturation in children undergoing congenital heart surgery. Am J Surg. 2005 Aug;190(2):260-3. doi: 10.1016/j.amjsurg.2005.05.023.

    PMID: 16023442BACKGROUND

  • Rezaei O, Pakdaman H, Gharehgozli K, Simani L, Vahedian-Azimi A, Asaadi S, Sahraei Z, Hajiesmaeili M. S100 B: A new concept in neurocritical care. Iran J Neurol. 2017 Apr 4;16(2):83-89.

    PMID: 28761630BACKGROUND

  • Stojanovic Stipic S, Carev M, Bajic Z, Supe Domic D, Roje Z, Jukic A, Stipic T. Increase of plasma S100B and neuron-specific enolase in children following adenotonsillectomy: a prospective clinical trial. Eur Arch Otorhinolaryngol. 2017 Oct;274(10):3781-3788. doi: 10.1007/s00405-017-4698-1. Epub 2017 Aug 7.

    PMID: 28785895BACKGROUND

  • Chen F, Duan G, Wu Z, Zuo Z, Li H. Comparison of the cerebroprotective effect of inhalation anaesthesia and total intravenous anaesthesia in patients undergoing cardiac surgery with cardiopulmonary bypass: a systematic review and meta-analysis. BMJ Open. 2017 Oct 11;7(10):e014629. doi: 10.1136/bmjopen-2016-014629.

    PMID: 29025825BACKGROUND

  • Pironkova RP, Giamelli J, Seiden H, Parnell VA, Gruber D, Sison CP, Kowal C, Ojamaa K. Brain injury with systemic inflammation in newborns with congenital heart disease undergoing heart surgery. Exp Ther Med. 2017 Jul;14(1):228-238. doi: 10.3892/etm.2017.4493. Epub 2017 May 22.

    PMID: 28672919BACKGROUND

MeSH Terms

Conditions

Heart Defects, CongenitalInfant, Premature, Diseases

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Boqun Cui, M.D.

    Beijing Anzhen Hospital

    STUDY CHAIR

Central Study Contacts

Jun Ma, M.D.,phD

CONTACT

+8601064456779majun7689@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: one group is treated with sevoflurane, the other is not.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Chief of Anesthesiology Department

Study Record Dates

First Submitted

November 21, 2017

First Posted

December 8, 2017

Study Start

January 20, 2018

Primary Completion

December 28, 2021

Study Completion

December 28, 2022

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

CN(1)