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

NCT03746340 | Unknown

• 1 other identifier: SH9H-2018-T53-2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthetic Toxicity

Keywords

sevoflurane; propofol; Folic Acid

Outcome Measures

Primary Outcomes (2)

• levels of folate in the perioperative serum

  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

  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.

Study Arms (1)

Anesthetic

Sevoflurane Group Propofol Group

Drug: Propofol; Drug: Sevoflurane

Interventions

Propofol DRUG

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.

Anesthetic

Sevoflurane DRUG

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

Anesthetic

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children under 3 years old who underwent general anesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hong Jiang, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 19, 2018
• Study Start: November 7, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

CN (1)