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NCT03366597 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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