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

Not Applicable

• Conditions: Homocysteine; Sevoflurane; Cochlear Hearing Loss; Propofol
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT03595163
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-04-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-23
• Last Update Posted: 2018-07-23
• Study Completion: 2018-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Sevoflurane	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 P	Propofol	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 .

Primary Outcome Measures

Name	Time	Method
Serum folate levels	Measured at Week 1	The serum folate concentration was detected by microparticle enzyme immunoassay.

Secondary Outcome Measures

Name	Time	Method
Plasma homocysteine levels	Measured at Week 1	The serum homocysteine concentration was detected by fluorescence polarization immunoassay.

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, China