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

Congenital Heart Disease Clinical Trial

Official title:

Effect of Sevoflurane on the Content of S100β in Infants With Congenital Heart Disease Undergo Cardiac Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03366597
• Other study ID #: 2017030X
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2021
• Source: Beijing Anzhen Hospital
• Contact: Jun Ma, M.D.,phD
• Phone: +8601064456779
• Email: majun7689[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of congenital heart disease

• Undergoing heart surgery with cardiopulmonary bypass

Exclusion Criteria:

• Pulmonary arterial hypertension

• Sevoflurane allergy

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Infant, Premature, Diseases

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jun Ma

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of S100ß protein	The concentration of S100ß 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	Level of regional cerebral oxygen saturation(rScO2)	The rScO2 was measured by using noninvasive near-infrared spectroscopy during cardiac surgery	5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative