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

Sponsor

Jun Ma (Other)

Overall Status

Recruiting

CT.gov ID

NCT03366597

Collaborator

(none)

100

Enrollment

Location

Arm

59.2

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Infant, Premature, Diseases	Drug: Sevoflurane	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

one group is treated with sevoflurane, the other is not.one group is treated with sevoflurane, the other is not.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2018

Anticipated Primary Completion Date :

Dec 28, 2021

Anticipated Study Completion Date :

Dec 28, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Concentration of S100β protein [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.)

Secondary Outcome Measures

Level of regional cerebral oxygen saturation(rScO2) [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