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

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

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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