The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children

November 14, 2018 updated by: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
The concentration of folic acid and homocysteine in the blood can be used as independent risk factors for a variety of diseases. A sustained decrease in blood folate concentration and an increase in homocysteine concentration can damage vascular endothelial cells, causing varying degrees of neurodevelopmental abnormalities. Many clinical studies have found that anesthetics can affect blood folate and homocysteine concentration, but the effects of sevoflurane and propofol on blood folate and homocysteine concentrations are not clear. Therefore, this study aims to investigate the effects of sevoflurane and propofol on blood folate and homocysteine levels in children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Retrospective study: Study the medical history of infants and young children (less than 3 years old) who underwent sevoflurane or propofol general anesthesia for more than 3 hours from January 2018 to December 2018, and compare the preoperative and postoperative serum folate changes for retrospective analysis.

Prospective study：Ten infants and young children (less than 3 years old) who underwent general anesthesia from November 7, 2018 to December 31, 2018 in Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Inhalation of 1-8% concentration of sevoflurane for general anesthesia induced intubation, followed by sevoflurane 2.0 ~ 2.5 Vol% inhalation maintenance, according to the intraoperative situation to add opioids. Patients maintained a bispectral index (BIS) monitoring between 50 and 60. After induction of general anesthesia in all patients, Serum folate levels were measured before the start of surgery, every 1 hour during surgery, and at the end of surgery.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children under 3 years old who underwent general anesthesia

Description

Inclusion Criteria:

  1. Children under 3 years old who underwent general anesthesia
  2. Those who did not participate in other clinical trials within 3 months
  3. No acute infectious diseases, systemic diseases
  4. The family member of the child agrees to the test and signs the informed consent form.

Exclusion Criteria:

  1. Refusal to join the group
  2. severe liver and kidney damage
  3. Hemodynamic instability (shock, blood pressure drop > 30% of basal blood pressure)
  4. Children with egg and milk allergy
  5. Children with a family history of malignant hyperthermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anesthetic
Sevoflurane Group Propofol Group
Drug: Propofol
Propofol group: intravenous Propofol (2.0mg / kg) for general anesthesia induction, maintained for 30~60s. Continuous intravenous infusion of Propofol (7~8 mg·kg-1·h-1) with a syringe pump maintains a smooth general anesthetic sedative effect.
Drug: Sevoflurane
Sevoflurane group: Inhalation of 1-8% sevoflurane for induction.Then Inhalation of sevoflurane (2.0~2.5Vol%) was maintained

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of folate in the perioperative serum
Time Frame: Change of serum folate levels from the beginning of anesthesia to the end.Serum folate levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
a Chemiluminescent Microparticle Folate Binding Protein assay with the ARCHITECT Folate Reagent Kit (Abbott Laboratories, IL, USA) was used to determine serum folate concentrations. Serum folate concentrations were quantified using the ARCHITECT i2000 SR System (Abbott Laboratories).
Change of serum folate levels from the beginning of anesthesia to the end.Serum folate levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
levels of homocysteine in the perioperative serum
Time Frame: Change of serum homocysteine levels from the beginning of anesthesia to the end.Serum homocysteine levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
Serum Hcy concentrations were analyzed by fluorescence polarization immunoassay using the IMx Homocysteine Reagent Pack and IMx Analyzer (Abbott Laboratories).
Change of serum homocysteine levels from the beginning of anesthesia to the end.Serum homocysteine levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Principal Investigator: Hong Jiang, MD,PhD, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2018

Primary Completion (ANTICIPATED)

March 31, 2019

Study Completion (ANTICIPATED)

March 31, 2019

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (ACTUAL)

November 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH9H-2018-T53-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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