ClinicalTrials.gg
Status unknownNCT03366597Updated Feb 11, 2021

The Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.

An interventional study of Sevoflurane in Congenital Heart Disease and Infant, Premature, Diseases, sponsored by Jun Ma. Status unknown at 1 site in China. Open to participants aged Up to 3 Years. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Jun Ma · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
Up to 3 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 79 studies in Heart Defects, Congenital with a site in China — 27 open to participants now, 30 under way, none of them phase 3. Heart Defects, Congenital · China.

Planned enrollment
29th of 41
100 · median 160
Started
2018
with 5 others
No phase
31 of 79
12 open now
Registered
27th of 79
by date

Among the 79 studies in Heart Defects, Congenital with a site in China, this one is the 29th largest by planned enrollment of the 41 interventional ones that give a count, is one of 6 that started in 2018, is one of 31 with no phase, and was the 27th registered.

Heart Defects, Congenital

991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.

Browse Heart Defects, Congenital studies →

Open to participants now

27 of the 79 studies in Heart Defects, Congenital with a site in China are open now. Recruiting first, the newest first:

22 more — sign in →

All 27 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.

This study: Up to 3 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Congenital Heart Disease
  • Infant, Premature, Diseases

Keywords

  • sevoflurane
  • S100β protein
  • regional cerebral oxygen saturation
  • infant
04

Who can participate

Ages eligible
Up to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pulmonary arterial hypertension
  • Sevoflurane allergy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Sevoflurane

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

    Drug: Sevoflurane

Interventions

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

06

What researchers measure

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.)

    Time frame: 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)

    The rScO2 was measured by using noninvasive near-infrared spectroscopy during cardiac surgery

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

07

Study locations

1 of 1 sites recruiting
  • Beijing Anzhen Hospital
    Beijing, Beijing 100038, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 16023442 ↗
  • 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. PubMed 28761630 ↗
  • 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. PubMed 28785895 ↗
  • 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. PubMed 29025825 ↗
  • 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. PubMed 28672919 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Dec 2021, 47 months after the start.

Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 47 months is above that.

Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2017
First posted
Dec 8, 2017
StartActual
Jan 20, 2018
Primary completionEst.
Dec 28, 2021
CompletionEst.
Dec 28, 2022
Last update
Feb 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03366597
Lead sponsor
Jun Ma
Responsible party
Jun Ma (The Chief of Anesthesiology Department, Beijing Anzhen Hospital) — Sponsor-investigator
First posted
Dec 8, 2017
Start date
Jan 20, 2018
Primary completion
Dec 28, 2021 (estimated)
Completion
Dec 28, 2022 (estimated)
Last update
Feb 11, 2021

Study contacts

Jun Ma, M.D.,phD
Contact
majun7689@163.com
+8601064456779
Boqun Cui, M.D.
study chair · Beijing Anzhen Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Sevoflurane

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