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

NCT02711280 | Completed

• 1 other identifier: [2014]114
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (4)

• 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

  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

• 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

• 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

Study Arms (2)

Sevoflurane General anesthesia

EXPERIMENTAL

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

Drug: Sevoflurane

Propofol General anesthesia

EXPERIMENTAL

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

Drug: Propofol

Interventions

Sevoflurane DRUG

Sevoflurane General anesthesia

Propofol DRUG

Propofol General anesthesia

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Xue Zhou, Master

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 17, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

CN (1)