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Completed

NCT Number: NCT02711280

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

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.

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Key information

Conditions

Age range

1 year–3 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevoflurane

Drug

Propofol

Drug

Primary outcomes

  1. the change of blood glutathione peroxidase(GPx) level in perioperative period

    Time frame: immediately after anesthetic induction, 2h and 3 days after operation

  2. the change of blood-separated erythrocytes superoxide dismutase (SOD) activities in perioperative period

    Time frame: 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).

  3. the change of blood-separated erythrocytes catalase (CAT) activities in perioperative period

    Time frame: 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)

  4. the change of blood-separated lymphocytes caspase-3 mRNA level in perioperative period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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