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

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ClinicalTrials.gov Identifier: NCT03595163
Recruitment Status : Enrolling by invitation
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Sevoflurane Propofol Homocysteine Cochlear Hearing Loss Drug: Sevoflurane Drug: Propofol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children With Cochlear Implant Surgery
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 30, 2018
Estimated Study Completion Date : October 30, 2018


Arm Intervention/treatment
Experimental: Group S
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
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.
Other Name: Blood Folic Acid and Homocysteine Concentrations

Active Comparator: Group P
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
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.
Other Name: Blood Folic Acid and Homocysteine Concentrations




Primary Outcome Measures :
  1. Serum folate levels [ Time Frame: Measured at Week 1 ]
    The serum folate concentration was detected by microparticle enzyme immunoassay.


Secondary Outcome Measures :
  1. Plasma homocysteine levels [ Time Frame: Measured at Week 1 ]
    The serum homocysteine concentration was detected by fluorescence polarization immunoassay.



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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595163


Locations
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China
Shanghai ninth people's hospital
Shanghai, China
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Director: Jiang Hong, Ph.D Shanghai9 hospital
Study Chair: Li Jingjie, Ph.D Shanghai9 hospital

Additional Information:
Publications:
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Responsible Party: Jingjie Li, vice-director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03595163     History of Changes
Other Study ID Numbers: 2018-121-T99
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Sevoflurane
Propofol
Folic Acid Concentrations
Homocysteine Concentrations
Cochlear Implant Surgery

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Propofol
Sevoflurane
Folic Acid
Vitamin B Complex
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances