Cochlear Hearing Loss, Homocysteine, Propofol, Sevoflurane
Conditions
Keywords
Sevoflurane, Propofol, Folic Acid Concentrations, Homocysteine Concentrations, Cochlear Implant Surgery
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.
Interventions
DRUGSevoflurane
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.
DRUGPropofol
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.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum folate levels | Measured at Week 1 | The serum folate concentration was detected by microparticle enzyme immunoassay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma homocysteine levels | Measured at Week 1 | The serum homocysteine concentration was detected by fluorescence polarization immunoassay. |
Countries
China
Outcome results
None listed