Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children
Study Details
Study Description
Brief Summary
To investigate the effect of sevoflurane and propofol on the concentrations of serum homocysteine and folic acid in children who received cochlear implant surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group S 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
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.
Other Names:
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| Active Comparator: Group P 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum folate levels [Measured at Week 1]
The serum folate concentration was detected by microparticle enzyme immunoassay.
Secondary Outcome Measures
- Plasma homocysteine levels [Measured at Week 1]
The serum homocysteine concentration was detected by fluorescence polarization immunoassay.
Eligibility Criteria
Criteria
Inclusion Criteria:
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children accepted cochlear implant surgery under general anesthesia
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no participate in any other trial up to 3 months before this study
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no acute infectious diseases, systemic diseases
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willing to participate in this study and sign the informed consent
Exclusion Criteria:
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unwilling to participate in this study
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with a history of serious liver or kidney dysfunction
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hemodynamic instability (etc. shock, blood pressure reduced by 30%)
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children with egg milk allergy
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children with a family history of malignant hyperthermia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai ninth people's hospital | Shanghai | China |
Sponsors and Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
- Study Director: Jiang Hong, Ph.D, Shanghai9 hospital
- Study Chair: Li Jingjie, Ph.D, Shanghai9 hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Cadoni G, Agostino S, Scipione S, Galli J. Low serum folate levels: a risk factor for sudden sensorineural hearing loss? Acta Otolaryngol. 2004 Jun;124(5):608-11.
- Coskunfirat N, Hadimioglu N, Ertug Z, Akbas H, Davran F, Ozdemir B, Aktas Samur A, Arici G. Homocysteine levels after nitrous oxide anesthesia for living-related donor renal transplantation: a randomized, controlled, double-blind study. Transplant Proc. 2015 Mar;47(2):313-8. doi: 10.1016/j.transproceed.2014.10.014. Epub 2015 Jan 31.
- Krapels IP, Vermeij-Keers C, Müller M, de Klein A, Steegers-Theunissen RP. Nutrition and genes in the development of orofacial clefting. Nutr Rev. 2006 Jun;64(6):280-8. Review.
- Martínez-Vega R, Garrido F, Partearroyo T, Cediel R, Zeisel SH, Martínez-Álvarez C, Varela-Moreiras G, Varela-Nieto I, Pajares MA. Folic acid deficiency induces premature hearing loss through mechanisms involving cochlear oxidative stress and impairment of homocysteine metabolism. FASEB J. 2015 Feb;29(2):418-32. doi: 10.1096/fj.14-259283. Epub 2014 Nov 10.
- Verkleij-Hagoort A, Bliek J, Sayed-Tabatabaei F, Ursem N, Steegers E, Steegers-Theunissen R. Hyperhomocysteinemia and MTHFR polymorphisms in association with orofacial clefts and congenital heart defects: a meta-analysis. Am J Med Genet A. 2007 May 1;143A(9):952-60.
- 2018-121-T99