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
|Condition or disease||Intervention/treatment|
|Anesthetic Toxicity||Drug: Propofol Drug: Sevoflurane|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|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|
Sevoflurane Group Propofol Group
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 group: Inhalation of 1-8% sevoflurane for induction.Then Inhalation of sevoflurane (2.0~2.5Vol%) was maintained
- 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).
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746340
|Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200011|
|Principal Investigator:||Hong Jiang, MD,PhD||Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine|