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

NCT ID: NCT03746340

Last Updated: 2018-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Anesthetic Toxicity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Anesthetic

Sevoflurane Group Propofol Group

Propofol

Intervention Type 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.

Sevoflurane

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Jiang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SH9H-2018-T53-2

Identifier Type: -

Identifier Source: org_study_id

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