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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711280
• Other study ID #: [2014]114
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: October 11, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 3 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• Sevoflurane

• Propofol

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of blood glutathione peroxidase(GPx) level in perioperative period		immediately after anesthetic induction, 2h and 3 days after operation	Yes
Primary	the change of blood-separated erythrocytes superoxide dismutase (SOD) activities in perioperative period	the blood sample was separated and erythrocytes was obtained, superoxide dismutase activity was measured using a commercially available assay-Ransod kit (Randox Laboratories, UK).	immediately after anesthetic induction, 2h and 3 days after operation	Yes
Primary	the change of blood-separated erythrocytes catalase (CAT) activities in perioperative period	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)	immediately after anesthetic induction, 2h and 3 days after operation	Yes
Primary	the change of blood-separated lymphocytes caspase-3 mRNA level in perioperative period	Lymphocytes were separated from whole blood and freshly used for real-time PCR of caspase-3	immediately after anesthetic induction, 2h and 3 days after operation	Yes