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

Propofol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03595163
• Other study ID #: 2018-121-T99
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural
• Homocysteine
• Propofol
• Sevoflurane

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

External Links

•   Methylene Tetrahydrofolate Reductase Deficiency: the Hidden Risk in Paediatric Anaesthesia.