The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children

NCT ID: NCT02711280

Last Updated: 2016-10-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to determine whether Propofol and Sevoflurane affect the oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.

Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sevoflurane General anesthesia

Anesthesia was induced with 8% sevoflurane with 8L/min oxygen. Anesthesia was maintained with 1-3% sevoflurane in oxygen/air mixture.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Propofol General anesthesia

Anesthesia was induced with propofol 4mg/kg. Anesthesia was maintained with propofol 7-12mg/kg/h.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Interventions

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Sevoflurane

Intervention Type DRUG

Propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiology (ASA) I-II, undergoing selective surgery for hypospadias repair.

Exclusion Criteria

* a history of developmental delay or mental retardation, which could make observational pain intensity assessment outside the norm;
* a history of central nervous system diseases;
* a known or suspected coagulopathy;
* a known allergy to any of the study drugs;
* abnormalities of the sacrum and any signs of infection at the site of the proposed caudal block.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Feng Xia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xue Zhou, Master

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, the First-Affiliated Hospital of Sun Yat-Sen University

Locations

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The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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[2014]114

Identifier Type: -

Identifier Source: org_study_id

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