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

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ClinicalTrials.gov Identifier: NCT03746340
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment
Anesthetic Toxicity Drug: Propofol Drug: Sevoflurane

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Other
Official Title: The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children under 3 years old who underwent general anesthesia
Criteria

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

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): NCT03746340


Locations
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China, Shanghai
Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Principal Investigator: Hong Jiang, MD,PhD Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine

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Responsible Party: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03746340     History of Changes
Other Study ID Numbers: SH9H-2018-T53-2
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
sevoflurane
propofol
Folic Acid
Additional relevant MeSH terms:
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Folic Acid
Vitamin B Complex
Propofol
Anesthetics
Sevoflurane
Anesthetics, General
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances