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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03746340
Enrollment
40
Registered
2018-11-19
Start date
2018-11-07
Completion date
2019-03-31
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetic Toxicity

Keywords

sevoflurane, propofol, Folic Acid

Brief summary

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.

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.

Interventions

DRUGPropofol

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.

DRUGSevoflurane

Sevoflurane group: Inhalation of 1-8% sevoflurane for induction.Then Inhalation of sevoflurane (2.0\ 2.5Vol%) was maintained

Sponsors

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

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
levels of folate in the perioperative serumChange 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).
levels of homocysteine in the perioperative serumChange 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026