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

Primary Purpose

Sevoflurane, Propofol, Homocysteine

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sevoflurane

Propofol

About this trial

This is an interventional other trial for Sevoflurane focused on measuring Sevoflurane, Propofol, Folic Acid Concentrations, Homocysteine Concentrations, Cochlear Implant Surgery

Eligibility Criteria

1 Month - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shanghai ninth people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group S

Group P

Arm Description

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 .

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 .

Outcomes

Primary Outcome Measures

Serum folate levels

The serum folate concentration was detected by microparticle enzyme immunoassay.

Secondary Outcome Measures

Plasma homocysteine levels

The serum homocysteine concentration was detected by fluorescence polarization immunoassay.

Full Information

NCT ID

NCT03595163

First Posted

July 2, 2018

Last Updated

July 12, 2018

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

1. Study Identification

Unique Protocol Identification Number

NCT03595163

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

October 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sevoflurane, Propofol, Homocysteine, Cochlear Hearing Loss

Keywords

Sevoflurane, Propofol, Folic Acid Concentrations, Homocysteine Concentrations, Cochlear Implant Surgery

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group S

Arm Type

Experimental

Arm Description

Arm Title

Group P

Arm Type

Active Comparator

Arm Description

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 .

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Other Intervention Name(s)

Blood Folic Acid and Homocysteine Concentrations

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

Blood Folic Acid and Homocysteine Concentrations

Intervention Description

Primary Outcome Measure Information:

Title

Serum folate levels

Description

The serum folate concentration was detected by microparticle enzyme immunoassay.

Time Frame

Measured at Week 1

Secondary Outcome Measure Information:

Title

Plasma homocysteine levels

Description

The serum homocysteine concentration was detected by fluorescence polarization immunoassay.

Time Frame

Measured at Week 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiang Hong, Ph.D

Organizational Affiliation

Shanghai9 hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Li Jingjie, Ph.D

Organizational Affiliation

Shanghai9 hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai ninth people's hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25384423

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.

Results Reference

background

PubMed Identifier

15267180

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.

Results Reference

background

PubMed Identifier

16808114

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.

Results Reference

background

PubMed Identifier

17431894

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.

Results Reference

background

PubMed Identifier

25648379

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.

Results Reference

background

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=Methylene+Tetrahydrofolate+Reductase+Deficiency%3A+the+Hidden+Risk+in+Paediatric+Anaesthesia.+Turk+J+Anaesthesiol+Reanim

Description

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

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

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