Clinical trial NCT03366597: The Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.
Official title: Effect of Sevoflurane on the Content of S100β in Infants With Congenital Heart Disease Undergo Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Infant, Premature, Diseases
Keywords: sevoflurane
S100β protein
regional cerebral oxygen saturation
infant
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 100
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one group is treated with sevoflurane, the other is not.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pulmonary arterial hypertension
* Sevoflurane allergy

Primary outcomes:
measure: Concentration of S100β protein
timeFrame: 5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative
Secondary outcomes:
measure: Level of regional cerebral oxygen saturation(rScO2)
timeFrame: 5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Boqun Cui, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.