Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02711280
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Feng Xia, 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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Drug: Sevoflurane Drug: Propofol Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711280


Locations
Layout table for location information
China, Guangdong
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Layout table for investigator information
Principal Investigator: Xue Zhou, Master Department of Anesthesiology, the First-Affiliated Hospital of Sun Yat-Sen University

Layout table for additonal information
Responsible Party: Feng Xia, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02711280     History of Changes
Other Study ID Numbers: [2014]114
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation