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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02711280

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General	Drug: Sevoflurane Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

The Effect of Sevoflurane and Propofol on Oxidative Stress and Apoptosis Status in Children Undergoing Hypospadias Repair Surgery

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane General anesthesia Anesthesia was induced with 8% sevoflurane with 8L/min oxygen. Anesthesia was maintained with 1-3% sevoflurane in oxygen/air mixture.	Drug: Sevoflurane
Experimental: Propofol General anesthesia Anesthesia was induced with propofol 4mg/kg. Anesthesia was maintained with propofol 7-12mg/kg/h.	Drug: Propofol

Arm

Intervention/Treatment

Experimental: Sevoflurane General anesthesia

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

Drug: Sevoflurane

Experimental: Propofol General anesthesia

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

Drug: Propofol

Outcome Measures

Primary Outcome Measures

the change of blood glutathione peroxidase(GPx) level in perioperative period [immediately after anesthetic induction, 2h and 3 days after operation]
the change of blood-separated erythrocytes superoxide dismutase (SOD) activities in perioperative period [immediately after anesthetic induction, 2h and 3 days after operation]
the blood sample was separated and erythrocytes was obtained, superoxide dismutase activity was measured using a commercially available assay-Ransod kit (Randox Laboratories, UK).
the change of blood-separated erythrocytes catalase (CAT) activities in perioperative period [immediately after anesthetic induction, 2h and 3 days after operation]
the blood sample was separated and erythrocytes was obtained, catalase activity was measured using the OxiSelect catalase activity assay (Cell Biolabs, San Diego, CA, USA)
the change of blood-separated lymphocytes caspase-3 mRNA level in perioperative period [immediately after anesthetic induction, 2h and 3 days after operation]
Lymphocytes were separated from whole blood and freshly used for real-time PCR of caspase-3

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 3 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Investigators

Principal Investigator: Xue Zhou, Master, Department of Anesthesiology, the First-Affiliated Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Feng Xia, Professor, First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT02711280

Other Study ID Numbers:

[2014]114

First Posted:

Mar 17, 2016

Last Update Posted:

Oct 12, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Propofol

Sevoflurane

Study Results

No Results Posted as of Oct 12, 2016