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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Homocysteine
Propofol
Sevoflurane
Cochlear Hearing Loss

Treatments

Drug: Propofol
Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT03595163
2018-121-T99

Details and patient eligibility

About

To investigate the effect of sevoflurane and propofol on the concentrations of serum homocysteine and folic acid in children who received cochlear implant surgery.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

1 month to 3 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Group S
Experimental group
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 .
Treatment:
Drug: Sevoflurane
Group P
Active Comparator group
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 .
Treatment:
Drug: Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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