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

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT02711280
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-13
• Study First Posted: 2016-03-17
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 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 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 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

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China