Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children

Study Overview
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Brief Summary
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To investigate the effect of sevoflurane and propofol on the concentrations of serum homocysteine and folic acid in children who received cochlear implant surgery.

Detailed Description
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This study is a prospective single center, cross-reference clinical application study.This study plan to enroll 40 children with cochlear implant surgery. Children were selected randomly and divided into 2 groups.Each group has 20 patients. All children undergo orotracheal intubation, mechanical ventilation will given by anaesthetic machine (U.S. Ohmeda advance cs2 ) to maintain oxygen saturation above 95%, hemodynamics and other vital signs were monitored with the anesthesia monitor.In the operation room,2-3ml arterial blood will be taken.And the levels of homocysteine and folic acid will be measured at week 1.

Official Title
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Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children With Cochlear Implant Surgery

Conditions
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Propofol, Sevoflurane, Homocysteine, Cochlear Hearing Loss

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children accepted cochlear implant surgery under general anesthesia no participate in any other trial up to 3 months before this study no acute infectious diseases, systemic diseases willing to participate in this study and sign the informed consent Exclusion Criteria: unwilling to participate in this study with a history of serious liver or kidney dysfunction hemodynamic instability (etc. shock, blood pressure reduced by 30%) children with egg milk allergy children with a family history of malignant hyperthermia

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group S<br>Children aged 1 month to 3 years who were scheduled to undergo cochlear implant surgery under general anesthesia were enrolled in this study.Children were treated with an infusion bolus of 2.0mg/kg propofol during anesthesia induction and maintained with 2.0-2.5vol% sevoflurane, with the dosage adjusted to achieve loss of consciousness.The bispectral index of EEG was maintained between 50 and 60 in all groups.The homocysteine and folic acid concentrations were measured after anesthesia induction and at the end of surgery separately . | Drug: Sevoflurane<br>* After anesthesia induction and at the end of the operation, all patients were taken 2-3ml arterial blood respectively.The blood was put at normal temperature for 30 minutes.Then the serum was centrifuged to measure the homocysteine and folic acid concentrations.<br>* Other names: Blood Folic Acid and Homocysteine Concentrations;|
| Active Comparator: Group P<br>Children aged 1 month to 3 years who were scheduled to undergo cochlear implant surgery under general anesthesia were enrolled in this study.Children were treated with an infusion bolus of 2.0mg/kg propofol during anesthesia induction and continuous infusion of 7 to 8mg/kg/hour, with the dosage adjusted to achieve loss of consciousness.The bispectral index of EEG was maintained between 50 and 60 in all groups.The homocysteine and folic acid concentrations were measured after anesthesia induction and at the end of surgery separately . | Drug: Propofol<br>* After anesthesia induction and at the end of the operation, all patients were taken 2-3ml arterial blood respectively.The blood was put at normal temperature for 30 minutes.Then the serum was centrifuged to measure the homocysteine and folic acid concentrations.<br>* Other names: Blood Folic Acid and Homocysteine Concentrations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum folate levels | The serum folate concentration was detected by microparticle enzyme immunoassay. | Measured at Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma homocysteine levels | The serum homocysteine concentration was detected by fluorescence polarization immunoassay. | Measured at Week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane, Propofol, Folic Acid Concentrations, Homocysteine Concentrations, Cochlear Implant Surgery