Clinical trial NCT03595163: Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children
Official title: Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children With Cochlear Implant Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sevoflurane
Propofol
Homocysteine
Cochlear Hearing Loss
Keywords: Sevoflurane
Propofol
Folic Acid Concentrations
Homocysteine Concentrations
Cochlear Implant Surgery
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum folate levels
timeFrame: Measured at Week 1
Secondary outcomes:
measure: Plasma homocysteine levels
timeFrame: Measured at Week 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
Study officials:
affiliation: Shanghai9 hospital
name: Jiang Hong, Ph.D
role: STUDY_DIRECTOR
affiliation: Shanghai9 hospital
name: Li Jingjie, Ph.D
role: STUDY_CHAIR
References:
citation: Martinez-Vega R, Garrido F, Partearroyo T, Cediel R, Zeisel SH, Martinez-Alvarez 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.
citation: 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. doi: 10.1080/00016480410016216.
citation: Krapels IP, Vermeij-Keers C, Muller M, de Klein A, Steegers-Theunissen RP. Nutrition and genes in the development of orofacial clefting. Nutr Rev. 2006 Jun;64(6):280-8. doi: 10.1111/j.1753-4887.2006.tb00211.x.
citation: 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. doi: 10.1002/ajmg.a.31684.
citation: 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.