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

NCT ID: NCT03366597

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2022-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease Infant, Premature, Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

one group is treated with sevoflurane, the other is not.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sevoflurane

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pulmonary arterial hypertension
* Sevoflurane allergy
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun Ma

OTHER

Sponsor Role lead

Responsible Party

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Jun Ma

The Chief of Anesthesiology Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Boqun Cui, M.D.

Role: STUDY_CHAIR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Ma, M.D.,phD

Role: CONTACT

+8601064456779

Facility Contacts

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Jun Ma, MD

Role: primary

010-64456329

References

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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.

Reference Type BACKGROUND
PMID: 16023442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28761630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28785895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29025825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28672919 (View on PubMed)

Other Identifiers

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2017030X

Identifier Type: -

Identifier Source: org_study_id

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