Back to resultsThe Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.
Primary Purpose
Congenital Heart Disease, Infant, Premature, Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring sevoflurane, S100β protein, regional cerebral oxygen saturation, infant
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of congenital heart disease
- Undergoing heart surgery with cardiopulmonary bypass
Exclusion Criteria:
- Pulmonary arterial hypertension
- Sevoflurane allergy
Sites / Locations
- Beijing Anzhen HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sevoflurane
Arm Description
Sevoflurane will be used as a narcotic drug in one group during cardiac surgery.
Outcomes
Primary Outcome Measures
Concentration of S100β protein
The concentration of S100β protein was performed using the electrochemiluminescence immunoassay.(Blood samples from patients were drawn from central intravenous.)
Secondary Outcome Measures
Level of regional cerebral oxygen saturation(rScO2)
The rScO2 was measured by using noninvasive near-infrared spectroscopy during cardiac surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03366597
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
December 28, 2021 (Anticipated)
Study Completion Date
December 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Ma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Infant, Premature, Diseases
Keywords
sevoflurane, S100β protein, regional cerebral oxygen saturation, infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one group is treated with sevoflurane, the other is not.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
Sevoflurane will be used as a narcotic drug in one group during cardiac surgery.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
1.5%-3% Sevoflurane will be given during the cardiac surgery except cardiopulmonary bypass.
Primary Outcome Measure Information:
Title
Concentration of S100β protein
Description
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 Outcome Measure Information:
Title
Level of regional cerebral oxygen saturation(rScO2)
Description
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of congenital heart disease
Undergoing heart surgery with cardiopulmonary bypass
Exclusion Criteria:
Pulmonary arterial hypertension
Sevoflurane allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ma, M.D.,phD
Phone
+8601064456779
Email
majun7689@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boqun Cui, M.D.
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD
Phone
010-64456329
Email
majun7689@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
16023442
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.
Results Reference
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PubMed Identifier
28761630
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.
Results Reference
background
PubMed Identifier
28785895
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.
Results Reference
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PubMed Identifier
29025825
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.
Results Reference
background
PubMed Identifier
28672919
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.
Results Reference
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The Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.
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