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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-10-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sevoflurane Propofol Homocysteine Cochlear Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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 .

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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.

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 .

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Blood Folic Acid and Homocysteine Concentrations Blood Folic Acid and Homocysteine Concentrations

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No