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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03595163
Other study ID # 2018-121-T99
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date October 30, 2018

Study information

Verified date July 2018
Source Shanghai 9th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date October 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Month to 3 Years
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
China Shanghai ninth people's hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum folate levels The serum folate concentration was detected by microparticle enzyme immunoassay. Measured at Week 1
Secondary Plasma homocysteine levels The serum homocysteine concentration was detected by fluorescence polarization immunoassay. Measured at Week 1
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