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

February 9, 2021 updated by: Jun Ma

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100038
        • Recruiting
        • Beijing Anzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pulmonary arterial hypertension
  • Sevoflurane allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sevoflurane
Sevoflurane will be used as a narcotic drug in one group during cardiac surgery.
Drug: Sevoflurane
1.5%-3% Sevoflurane will be given during the cardiac surgery except cardiopulmonary bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of S100β protein
Time Frame: 5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative
The concentration of S100β 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of regional cerebral oxygen saturation(rScO2)
Time Frame: 5 minutes after tracheal intubation; immediately after cardiopulmonary bypass; immediately after operation; 12 hours, 24 hours postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Ma

Investigators

  • Study Chair: Boqun Cui, M.D., Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2018

Primary Completion (ANTICIPATED)

December 28, 2021

Study Completion (ANTICIPATED)

December 28, 2022

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (ACTUAL)

December 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017030X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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