Pediatric Frontal and Nasal Bispectral Index

Mahidol University40 enrolled

Overview

To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.

Standard position of frontal bispectral index (BIS) may not be available in some operations that frontal area is occupied by surgical field. This prospective cohort study aims to compare the accuracy of the BIS between an alternative position across the nasal area with the standard frontal BIS position in pediatric patients undergoing general anesthesia.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

BIS

Interventions

Bispectral index (BIS)DEVICE

* All patient will receive standard monitoring (EKG, Blood pressure, pulse oximetry), and BIS transducer placement at standard frontal area before anesthesia. * Sedative medication can be given as appropriate. * Anesthesia induction by inhalation induction with sevoflurane (if intravenous line not presented) or intravenous induction with thiopental 5-6 mg/kg IV * Other medication including fentanyl 1 mcg/kg IV and cisatracurium 0.1-0.2 mg/kg IV will be given and the patient will be intubated. * The second BIS will be installed on the bridge of the nose and temporal on the same side as frontal BIS. * The patient will be maintained with sevoflurane and other anesthetic drugs as appropriate, adjusted per frontal BIS (40-60). * The frontal BIS and the nasal BIS will be measured until the endotracheal tube is being removed. If the patient has moved until it was impossible to measure the BIS or has any necessity to cancel the BIS measurement. The BIS measurement can be stopped.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric patients undergoing general anesthesia * American Society of Anesthesiologists physical status 1-3 Exclusion Criteria: * Patients with neurological diseases * Patients who are using anticonvulsant drugs * Patients who is expected to be intubated and return to the pediatric intensive care unit * Patients undergoing head and face surgery * Patients undergoing surgery in the prone position * Patients who have contraindications to sevoflurane, thiopental, fentanyl, and cisatracurium

Locations (1)

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Outcomes

Primary Outcomes

bispectral index (BIS) value

BIS is a processed electroencephalogram (range from 0-100), the optimal value of BIS during general anesthesia is 40-60. We aim to define the differences between standard frontal BIS and nasal BIS using Bland-Altman analysis.

Time frame: 5 hours

Secondary Outcomes

signal quality index (SQI)

SQI (range from 0-100) determines the quality of signal of the primary outcome (BIS). We aim to define the differences of SQI of BIS between standard frontal and nasal positions.

Time frame: 5 hours

electromyography (EMG)

EMG (range from 0-100) reports the interference of muscle activity on quality of the primary outcome (BIS). We aim to define the differences of EMG between standard frontal and nasal positions.

Time frame: 5 hours

Data from ClinicalTrials.gov

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