NCT03595163

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

July 2, 2018

Last Update Submit

July 12, 2018

Conditions

SevofluranePropofolHomocysteineCochlear Hearing Loss

Keywords

SevofluranePropofolFolic Acid ConcentrationsHomocysteine ConcentrationsCochlear Implant Surgery

Outcome Measures

Primary Outcomes (1)

  • Serum folate levels

    The serum folate concentration was detected by microparticle enzyme immunoassay.

    Measured at Week 1

Secondary Outcomes (1)

  • Plasma homocysteine levels

    Measured at Week 1

Study Arms (2)

Group S

EXPERIMENTAL

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 .

Drug: Sevoflurane

Group P

ACTIVE COMPARATOR

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 .

Drug: Propofol

Interventions

SevofluraneDRUG

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.

Also known as: Blood Folic Acid and Homocysteine Concentrations
Group S
PropofolDRUG

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.

Also known as: Blood Folic Acid and Homocysteine Concentrations
Group P

Eligibility Criteria

Age1 Month - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, China

Location

Related Publications (5)

  • 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.

    PMID: 25384423BACKGROUND

  • 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.

    PMID: 15267180BACKGROUND

  • 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.

    PMID: 16808114BACKGROUND

  • 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.

    PMID: 17431894BACKGROUND

  • 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.

    PMID: 25648379BACKGROUND

Related Links

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Jiang Hong, Ph.D

    Shanghai9 hospital

    STUDY DIRECTOR

  • Li Jingjie, Ph.D

    Shanghai9 hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice-director

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 23, 2018

Study Start

January 1, 2018

Primary Completion

April 30, 2018

Study Completion

October 30, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)