Clinical trial NCT03746340: The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children
Official title: The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthetic Toxicity
Keywords: sevoflurane
propofol
Folic Acid
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children under 3 years old who underwent general anesthesia

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.

Eligibility 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

Primary outcomes:
measure: levels of folate in the perioperative serum
timeFrame: 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.
measure: levels of homocysteine in the perioperative serum
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Hong Jiang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: